Ankle replacement system and method

ABSTRACT

Various surgical devices and methods are disclosed herein. Also disclosed is multi-component prosthesis, which can be used as an ankle prosthesis. One of the disclosed surgical alignment systems includes a guide arm, a ratchet arm frame configured to be coupled slidably to the guide arm, a ratchet arm configured to be coupled to the ratchet arm frame, and a sagittal sizing guide body configured to be coupled to the ratchet arm. The sagittal sizing guide body includes a first radiopaque object disposed at a first position and a second radiopaque object disposed at a second position that is spaced apart from the first position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a national phase entry under 35 U.S.C. 371 ofinternational patent application PCT/US2014/027448, filed Mar. 14, 2014,which claims priority to U.S. Provisional Patent Application No.61/782,507, flied Mar. 14, 2013, and to U.S. Provisional PatentApplication No. 61/846,831, filed Jul. 16, 2013, and is acontinuation-in-part of U.S. patent application Ser. No. 14/100,799,filed Dec. 9, 2013, which claims priority to U.S. Provisional PatentApplication No. 61/746,393, filed Dec. 27, 2012, the entireties of whichare herein incorporated by reference.

FIELD

This disclosure relates to prosthetics generally, and more specificallyto systems and methods for total ankle replacement.

BACKGROUND

The ankle is a joint that acts much like a hinge. The joint is formed bythe union of three bones. The ankle bone is the talus. The top of thetalus fits inside a socket that is formed by the lower end of the tibia,and the fibula, the small bone of the lower leg. Arthritis, bonedegeneration, and/or injury can cause ankle joint deteriorationresulting in pain, reduced range of motion, and decreased quality oflife. In many cases, physicians are recommending ankle replacementsurgery with an implant as an option. Consequently, improved systems andmethods of providing ankle replacement surgery are desirable.

SUMMARY

In some embodiments, a surgical alignment system includes a guide arm, aratchet arm frame configured to be coupled slidably to the guide arm, aratchet arm configured to be coupled to the ratchet arm frame, and asagittal sizing guide body configured to be coupled to the ratchet arm.The sagittal sizing guide body includes a first radiopaque objectdisposed at a first position and a second radiopaque object disposed ata second position that is spaced apart from the first position.

In some embodiments, a method includes coupling a guide arm to a firstfixture coupled to a first bone and inserting an end of the guide arminto an opening defined by a ratchet arm frame. The ratchet arm frame iscoupled to a ratchet arm that extends in a first longitudinal directionthat is different from a direction in which the guide arm extends alongits length. The ratchet arm is inserted into a channel defined by asagittal sizing guide body to couple the sagittal sizing guide body tothe ratchet arm. The sagittal sizing guide body includes a firstradiopaque object disposed at a first position and a second radiopaqueobject disposed at a second position that is spaced apart from the firstposition.

In some embodiments, a method includes inserting a dovetail extension ofa coronal sizing and drill guide into a cavity of a dovetail joint of anadjustment block that is coupled to a tibia, securing the dovetailextension within the cavity, and using fluoroscopy to check a size of aradiopaque element of the coronal sizing and drill guide relative to atleast the tibia. The radiopaque element has a size and shape thatcorresponds to a profile of a prosthesis component of a first typehaving a first size when viewed in an anterior-posterior direction.

In some embodiments, a surgical positioning system includes a firstcomponent including an elongate shaft coupled to a head. The head isconfigured to be disposed in a joint between a first bone and a secondbone. A second component includes diverging first and second portions.The first portion defines a hole that is sized and configured to receivethe shaft of the first component. The second portion defines a firstchannel on a first side. A third component is configured to be coupledto the second component. The third component includes a base and apointer extension. The base includes a protrusion that is sized andconfigured to be received slidably within the first slot.

In some embodiments, a method includes inserting a head of a firstcomponent of a surgical positioning system into a joint between a firstbone and a second bone and sliding a second component of the surgicalpositioning system onto a shaft of the first component. The secondcomponent includes diverging first and second portions. The firstportion defines a hole that is sized and configured to receive the shaftof the first component, and the second portion defines a first channelon a first side. A third component of the surgical positioning system isslid into engagement with the second component by inserting a protrusionof the third component into the first channel defined by the secondcomponent.

In some embodiments, a cutting system includes a cutting base having abody defining a slot, a first set of holes, and a second set of holes.The first set of holes being positioned along a first flange extendingaway from the slot in a first direction, and the second set of holesbeing positioned along a second flange extending from the slot in asecond direction that is opposite the first direction. A first cuttingguide has a body defining a plurality of holes that overlap one anotherto form a slot having a width that is smaller than a width of the slotdefined by the cutting base. The first cutting guide includes a set ofpegs that extend inferiorly from the first cutting guide and are sizedand configured to be received with the first set of holes or the secondset of holes to secure the first cutting guide to the cutting base.

A method includes coupling a cutting base to a resected surface of afirst bone. The cutting base includes a body defining a slot, a slitwithin the slot, a first set of holes, and a second set of holes. Thefirst set of holes being positioned along a first flange extending awayfrom the slot in a first direction, and the second set of holes beingpositioned along a second flange extending from the slot in a seconddirection that is opposite the first direction. A chamfer cut of thefirst bone is made by inserting a saw into the slit. A first cuttingguide is coupled to the cutting guide base by inserting inferiorlyextending pegs into the first set of holes. The first cutting guide hasa body defining a plurality of holes that overlap one another to form aslot having a width that is smaller than a width of the slot defined bythe cutting base. A reamer is plunged into each of the plurality ofholes defined by the first cutting guide to form a first flat. The firstcutting guide is rotated relative to the cutting guide base and iscoupled to the cutting guide base by inserting the inferiorly extendingpegs into the second set of holes. A reamer is plunged into each of theplurality of holes defined by the first cutting guide to form a secondflat.

In some embodiments, a surgical device includes a body including ahandle disposed at a first end and a locking protrusion extending adirection away from a longitudinal direction of the body. The lockingprotrusion defines an opening that is sized and configured to receive alocking tab therein and defining a hole that extends parallel to thelongitudinal direction of the body. The locking tab defines an aperturehaving first and second portions in which the first portion is narrowerthan the second portion. A pair of spaced apart rails are configured tobe disposed along a length of the body. A plunger rod is sized andconfigured to be received slidably within a threaded hole defined by thehandle, the aperture defined by the locking tab, and the hole defined bythe locking protrusion. The surgical device is configured to be coupledreleasably to a first implant component and to guide a second implantcomponent into position with respect to the first implant component.

In some embodiments, a method includes coupling an insertion device to afirst implant component disposed within a joint, pushing a plunger rodof the insertion device axially to advance a second implant componentalong a body of the insertion device between a pair of spaced apartrails until a threaded portion of the plunger rod contacts a threadedhole defined by a handle of the insertion device, and rotating a handleof the plunger rod relative to the body of the insertion device suchthat the threads of the threaded portion of the plunger rod engagethreads of the threaded hole to advance the second implant componentinto engagement with the first implant component.

A method includes placing a guide having a patient-specific surface on afirst bone. The guide includes a pin holder that engages a pin thatextends in a direction that is parallel to an axis of the first bone. Aplurality of pins are inserted into the guide. The guide is slid alongthe plurality of pins to remove the guide from contacting the firstbone. A conversion instrument is slid over a first subset of theplurality of pins, and a sizing and drill guide is slid over a secondsubset of the plurality of pins. The conversion instrument is coupled tothe sizing and drill guide by inserting a dovetail extension of thesizing and drill guide into a cavity of a dovetail joint of theconversion instrument.

In some embodiments, a surgical system includes a trial and a spacer.The trial is configured to be received within a resected first bone. Thetrial includes a plate having a bottom surface defining a channel. Thespacer has an elongate body and an extension disposed at one endthereof. The elongate body is sized and configured to be received withinchannel defined by the trial. The extension defining at least first andsecond holes that are configured to receive first and second pinspositioned within a second bone.

In some embodiments, a method includes inserting an elongate body of aspacer into a channel defined by a trial positioned within a resectedfirst bone, inserting first and second pins through first and secondholes defined by an extension of the spacer that extends superiorly fromthe elongate body; and removing the spacer and the trial while leavingthe first and second pins positioned within the second bone. A cuttingguide is slid over the first and second pins.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are isometric views of a medial gutter fork inaccordance with some embodiments.

FIGS. 2A and 2B are isometric views of a rotation guide slide inaccordance with some embodiments.

FIGS. 2C and 2D are side profile views of a rotation slide guide inaccordance with some embodiments.

FIGS. 3A and 3B are isometric views of a rotation guide pointer inaccordance with some embodiments.

FIG. 3C is a side profile view of a rotation guide pointer in accordancewith some embodiments.

FIG. 4A is an isometric view of an assembled rotation guide assemblycomprising a medial gutter fork, rotation guide slide, and rotationguide pointer in accordance with some embodiments.

FIG. 4B is an isometric view of an assembled rotation guide assemblywith first guide pin inserted in accordance with some embodiments.

FIG. 5 is an isometric view of a tibia with first guide pin inserted inaccordance with some embodiments.

FIG. 6 is an isometric view of one example of a proximal alignment framesub-assembly in accordance with some embodiments.

FIG. 7 is an isometric view of one example of a distal alignment framesub-assembly in accordance with some embodiments.

FIG. 8 is an isometric view of one example of a knee bracket inaccordance with some embodiments.

FIG. 9 is an isometric view of one example of a rubber strap inaccordance with some embodiments.

FIG. 10 is an isometric view of one example of an angel wing alignmentguide in accordance with some embodiments.

FIG. 11 is an isometric view of one example of an alignment rod inaccordance with some embodiments.

FIG. 12 is an isometric view of one example of an alignment frameassembly comprising the proximal alignment frame and the distalalignment frame attached to a bone via distal and proximal tibial pinsin accordance with some embodiments.

FIGS. 13A, 13B, and 13C are isometric views of some examples of analternative alignment frame assembly comprising the proximal alignmentframe and the distal alignment frame attached to a bone via first guidepin on a distal end of the distal alignment frame and attached to theknee bracket on a proximal end of the proximal alignment frame.

FIG. 14 is an isometric view of one example of an adjustment mechanismto lock the distal end of the distal alignment frame to the distaltibial pin in accordance with some embodiments.

FIG. 15 is an isometric view of one example of an adjustment mechanismto lock the proximal end of the proximal alignment frame to the proximaltibial pin in accordance with some embodiments.

FIG. 16 is an isometric view of one example of an adjustment mechanismto lock the proximal end of the proximal alignment frame to the kneebracket in accordance with some embodiments.

FIG. 17 is an isometric view of one example of the angel wing alignmentguide attached to the distal end of the distal alignment frame, which isconnected to the bone via the distal tibial pin in accordance with someembodiments.

FIG. 18 is an isometric view of one example of an adjustment mechanismfor coronal rotation in accordance with some embodiments.

FIG. 19 is an isometric view of one example of a hex driver inaccordance with some embodiments.

FIG. 20 is one example of a fluoroscopic image of the angel wingalignment guide attached to the distal end of the distal alignmentframe, which is connected to the bone via the distal tibial pin inaccordance with some embodiments.

FIG. 21 is an isometric view of one example of an alignment guideassembly comprising the angel wing alignment guide, alignment rod andalignment frame assembly in accordance with some embodiments.

FIG. 22 is an isometric view of one example an adjustment mechanism forsagittal rotation in accordance with some embodiments.

FIG. 23 is one example of a fluoroscopic image of the alignment guideassembly comprising the angel wing alignment guide, alignment rod andalignment frame assembly in accordance with some embodiments.

FIGS. 24A and 24B are isometric views of one example of a pin sleeve andtrocar in accordance with some embodiments.

FIG. 25 is an isometric view of two pin sleeves inserted into the distalend of the distal alignment frame in accordance with some embodiments.

FIG. 26 is an isometric view of one example of the trocar inserted intoone of the pin sleeves that is inserted into the distal end of thedistal alignment frame in accordance with some embodiments.

FIG. 27 is an isometric view of two pins inserted into the pin sleevesthat are inserted into the distal end of the distal alignment frame inaccordance with some embodiments.

FIG. 28 is an isometric view of the two pins attached to the bone afterthe pin sleeves, alignment frame assembly, distal tibial pin, andproximal tibial pin or knee bracket and rubber strap are removed inaccordance with some embodiments.

FIG. 29 is an isometric view of a position adjustment device, oradjustment block suitable for sizing and trialing an implant.

FIG. 30 is an exploded view showing the adjustment block, tibial trial,poly trial insert, and floating trial.

FIG. 31 is an isometric view of the tibia trial of FIG. 30.

FIG. 32 is an anterior elevation view of the tibia trial of FIG. 31.

FIG. 33 is a lateral elevation view of the tibia trial of FIG. 31.

FIG. 34 is an isometric view of the floating trial of FIG. 30.

FIG. 35 is an isometric view of an adjustment block of FIG. 29, holdinga drilling guide.

FIG. 36 is an isometric view of the adjustment block and drilling guideof FIG. 35, during the drilling operation.

FIG. 37 is an isometric view of the adjustment block of FIG. 29, holdinga cut guide.

FIG. 38 is an isometric view showing the adjustment block and tibialtrial during trial insertion.

FIG. 39 is a lateral side elevation view of the adjustment block andtibial trial during trial insertion.

FIG. 39A is a front side view of a spacer coupled to a tibial trial inaccordance with some embodiments.

FIG. 39B is a side view of the spacer coupled to the tibial trial inaccordance with some embodiments.

FIG. 39C illustrates the spacer and tibial trial being removed andreplaced with a cutting guide in accordance with some embodiments.

FIGS. 39D and 39E illustrate another example of a cutting guidepositioned over fixation pins placed using the tibial trial and spacerin accordance with some embodiments.

FIG. 40 is an isometric view showing drilling using the tibia trial tolocate peg holes in the distal surface of the tibia.

FIG. 41 shows the tibia and talus after resectioning.

FIG. 42 is an isometric view showing the adjustment block, tibial trial,poly trial insert, and floating trial inserted in the surgical window.

FIG. 43 is a lateral side elevation view of the adjustment block, tibialtrial, poly trial insert, and floating trial inserted in the surgicalwindow.

FIGS. 44 and 45 are isometric and lateral side elevation views showingthe adjustment block, tibial trial, poly trial insert, and floatingtrial inserted while the floating trial is being pinned to the talus.

FIG. 46 is an isometric view of an embodiment of the adjustment blockproviding proximal-distal and medial-lateral adjustments.

FIG. 47 is an anterior top plan view of the adjustment block of FIG. 46,with a drill guide attached to its tool holder.

FIG. 48 is an isometric view of a guide arm of a sagittal sizing guideassembly disposed above an ankle joint in accordance with someembodiments.

FIG. 49 is an isometric view of a guide arm received within a ratchetarm frame of a sagittal sizing guide assembly in accordance with someembodiments.

FIG. 50 is an isometric view of a sagittal sizing guide assemblydisposed adjacent to an ankle joint in accordance with some embodiments.

FIG. 51 is an isometric view of a sagittal sizing guide assembly coupledto a coronal sizing guide supported by an adjustment block in accordancewith some embodiments.

FIG. 52 is a side view of a sagittal sizing guide assembly coupled to acoronal sizing guide supported by an adjustment block in accordance withsome embodiments.

FIG. 53 is a side view of select components of the sagittal sizing guideassembly in accordance with some embodiments.

FIG. 54 is a side view of select components of the sagittal sizing guideassembly in accordance with some embodiments.

FIGS. 55A, 55B, 55C, 55D, 55E, and 55F are various isometric views ofone example of a talar resection guide base in accordance with someembodiments.

FIG. 56 is an isometric view of one example of an anterior talar pilotguide in accordance with some embodiments.

FIG. 57 is an isometric view of one example of the talar resection guidebase and the anterior talar pilot guide attached to one another inaccordance with some embodiments.

FIG. 58 is an isometric view of one example of an anterior talar finishguide in accordance with some embodiments.

FIG. 59 is an isometric view of one example the talar resection guidebase and the anterior talar finish guide attached to one another inaccordance with some embodiments.

FIG. 60 is an isometric view of one example of the talar resection guidebase attached to a bone via pins previously inserted in a talus inaccordance with some embodiments.

FIG. 61 is an isometric view of one example of a temporary fixationscrew or pin and a T-handle pin driver in accordance with someembodiments.

FIG. 62A is an isometric view of one example of the talar resectionguide base attached to the bone via two temporary fixation screws orpins in accordance with some embodiments.

FIG. 62B is an isometric view of one example of the talar resectionguide base attached to the bone via three temporary fixation screws orpins in accordance with some embodiments.

FIG. 63 is an isometric view of one example of a saw blade or bone sawinserted into the slit of one example of the talar resection guide baseattached to the bone via temporary fixation screws or pins in accordancewith some embodiments.

FIG. 64 is an exploded lateral side view of one example of a saw bladeor bone saw inserted into the slit of one example of the talar resectionguide base attached to the bone via temporary fixation screws or pins inaccordance with some embodiments.

FIG. 65 is an isometric view of one example of the talar resection guidebase and the anterior talar pilot guide attached to the bone viatemporary fixation screws or pins in accordance with some embodiments.

FIG. 66 is an isometric view of one example of the talar reamer inaccordance with some embodiments.

FIG. 67 is an isometric view of one example of the talar reamer insertedthrough the interconnecting holes of the talar resection guide base andthe slot of the anterior talar pilot guide attached to the bone viatemporary fixation screws or pins in accordance with some embodiments.

FIG. 68 is an isometric view of one example of the talar resection guidebase and the anterior talar pilot guide attached to the bone viatemporary fixation screws or pins following a 180° rotation of theanterior talar pilot guide in accordance with some embodiments.

FIG. 69 is an isometric view of one example of the talar reamer insertedthrough the interconnecting holes of the talar resection guide base andslot of the anterior talar pilot guide attached to the bone viatemporary fixation screws or pins following a 180° rotation of theanterior talar pilot guide in accordance with some embodiments.

FIG. 70 is an isometric view of one example of the talar resection guidebase and the anterior talar finish guide attached to the bone viatemporary fixation screws or pins in accordance with some embodiments.

FIG. 71 is an isometric view of one example of the talar reamer insertedthrough the slots of the talar resection guide base and the anteriortalar finish guide attached to the bone via temporary fixation screws orpins in accordance with some embodiments.

FIG. 72 is an isometric view of one example of the talar resection guidebase and the anterior talar finish guide attached to the bone viatemporary fixation screws or pins following a 180° rotation of theanterior talar finish guide in accordance with some embodiments.

FIG. 73 is an isometric view of one example of the talar reamer insertedthrough the slots of the talar resection guide base and the anteriortalar finish guide attached to the bone via temporary fixation screws orpins following a 180° rotation of the anterior talar finish guide inaccordance with some embodiments.

FIG. 74 is an isometric view of the talus bone following resection ofthe posterior and anterior talar chamfer and the anterior talar flat inaccordance with some embodiments.

FIG. 75 is an isometric view of one example of a talar peg drill guidein accordance with some embodiments

FIG. 76 is an isometric view of one example of a talar implant holder inaccordance with some embodiments.

FIG. 77 is an isometric view of one example of the talar peg drillguide, the tibial tray trial, and poly insert trial inserted into aresected area of the bone in accordance with some embodiments.

FIG. 78 is an isometric view of one example of the talar peg drill guideattached to the bone via a pin in accordance with some embodiments.

FIG. 79 is an isometric view of one example of an anterior peg drill inaccordance with some embodiments.

FIG. 80 is an isometric view of one example of an anterior peg drillinserted into a hole of the talar peg drill guide attached to the bonevia a pin in accordance with some embodiments.

FIG. 81 is an isometric view of the tibia and talus bone followingcreation of two holes using the anterior peg drill and talar peg drillguide in accordance with some embodiments.

FIG. 82 is an isometric view of one example of a tibial tray impactioninsert in accordance with some embodiments.

FIG. 83 is an inferior side view of one example of a tibial trayimpaction insert in accordance with some embodiments.

FIG. 84 is an isometric view of one example of a tibial tray inaccordance with some embodiments.

FIG. 85 is an inferior side view of one example of a tibial tray inaccordance with some embodiments.

FIG. 86 is an isometric view of one example of the tibial tray impactioninsert attached to a tibial tray in accordance with some embodiments.

FIG. 87 is an isometric view of one example of an insertion handle inaccordance with some embodiments.

FIG. 88 is an isometric view of one example of the insertion handleattached to the tibial tray impaction insert and tibial tray which isbeing inserted into the bone in accordance with some embodiments.

FIG. 89 is an isometric view of one example of a disassembled polyinserter in accordance with some embodiments.

FIG. 90 is an isometric view of one example of an assembled polyinserter in accordance with some embodiments.

FIG. 91 is an isometric view of one example of a poly insert guide railin accordance with some embodiments.

FIG. 92 is an isometric view of a poly inserter connected to a polyinsert guide rail and a poly insert implant in accordance with someembodiments.

FIGS. 93A and 93B are isometric views of attachment screws installed inthe tibial tray in accordance with some embodiments.

FIG. 94 is an isometric view of a poly inserter connected to attachmentscrews installed in the tibial tray in accordance with some embodiments.

FIGS. 95A and 95B are lateral side elevation views of the poly inserterinserting a poly insert implant in accordance with some embodiments.

FIG. 96 is an isometric view of an ankle replacement prosthesis inaccordance with some embodiments.

FIG. 97 is a side view of an ankle replacement prosthesis in accordancewith some embodiments.

FIG. 98 is a front side view of an ankle replacement prosthesis inaccordance with some embodiments.

FIG. 99 is a side view of an ankle replacement prosthesis disposedwithin an ankle joint in accordance with some embodiments.

FIG. 100 is an isometric view of one example of a patient-specificlocator guide coupled to a distal end of a tibia in accordance with someembodiments.

FIG. 101 is an isometric view of one example of a coronal sizing anddrill guide and a conversion instrument that are positioned on a distalend of the tibia based on the pins placed by the patient-specificlocator guide illustrated in FIG. 100 in accordance with someembodiments.

FIG. 102 is a front side view of the conversion instrument illustratedin FIG. 101 in accordance with some embodiments.

FIG. 103 is a side profile view of the conversion instrument illustratedin FIG. 101 in accordance with some embodiments.

FIG. 104 is a bottom side view of the conversion instrument illustratedin FIG. 101 in accordance with some embodiments.

FIG. 105 is a side profile view of the conversion instrument illustratedin FIG. 101 showing the inter components in accordance with someembodiments.

DETAILED DESCRIPTION

This description of the exemplary embodiments is intended to be read inconnection with the accompanying drawings, which are to be consideredpart of the entire written description. In the description, relativeterms such as “lower,” “upper,” “horizontal,” “vertical,”, “above,”“below,” “up,” “down,” “top” and “bottom” as well as derivative thereof(e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should beconstrued to refer to the orientation as then described or as shown inthe drawing under discussion. These relative terms are for convenienceof description and do not require that the apparatus be constructed oroperated in a particular orientation. Terms concerning attachments,coupling and the like, such as “connected” and “interconnected,” referto a relationship wherein structures are secured or attached to oneanother either directly or indirectly through intervening structures, aswell as both movable or rigid attachments or relationships, unlessexpressly described otherwise.

Rotation Guide Assembly

FIGS. 1-3 illustrate the one example of a rotation guide assembly 40 inaccordance with some embodiments. In some embodiments, rotation guideassembly 40 includes a medial gutter fork 10, a rotation guide slide 20,and a rotation guide pointer 30. FIGS. 4A and 4B illustrate the rotationguide assembly 40 assembled together in accordance with someembodiments. The rotation guide assembly 40 assists in the accurateplacement of a first guide pin 50 which serves as a guide for alignmentframe assembly 140 discussed in greater detail below.

Referring again to FIGS. 1A and 1B, medial gutter fork 10 includes ashaft 2 and a head 4. In some embodiments, shaft 2 has a cylindricalgeometry and includes a proximal end 3 and a distal end 5 each being ofa first diameter A, and an inner section 1 disposed between proximal end3 and distal end 5 and having a second diameter B. In some embodiments,the first diameter A is greater than second diameter B. Head 4 has atransitional portion 8, which is connected to the distal end 5 of shaft2, and a forked portion 7 including a pair of prongs 6. As described ingreater detail below, medial gutter fork 10 is configured to be insertedinto the medial gutter of an ankle joint to serve as a reference pointto the additional elements of the rotation guide assembly 40. In someembodiments, the head 4 does not have a forked shape

FIGS. 2A and 2B are isometric views of a rotation guide slide 20. Insome embodiments, rotation guide slide 20 has an “L” shaped bodyincluding a first portion 12 extending longitudinally in a firstdirection and a second portion 14 extending laterally from the firstportion 12 in a second direction. In some embodiments, first portion 12is longer than second portion 14 and the first and second directions areperpendicular with respect to one another. First portion 12 defines afirst channel 16 that runs the length of first portion 12 on a firstside 13 and defines a second channel 17 on second side 15, which isdisposed opposite the first side 13. Second portion 14 defines a guidehole 18 which is configured to engage the shaft 2 of medial gutter fork10. In some embodiments, hole 18 is located at the approximate center ofsecond portion 14; however, hole 18 can be located at other positions ofsecond portion 14. Another hole 19 is defined by the side of secondportion 14 and is sized and configured to receive a set screw (notshown) for locking the position of rotation guide slide 20 relativegutter fork 10.

FIG. 2C illustrates one example of a configuration of channel 16 inaccordance with some embodiments. Channel 16 is illustrated as having aflat bottom surface 16 a and angled side walls 16 b and 16 c that taperinwardly such that the top of channel 16 is narrower than the bottom.Second channel 17 is aligned along the same longitudinal axis as firstchannel 16 and is shaped identical to first channel 16 with a flatbottom surface 17 a and angled side walls 17 b and 17 c that taperinwardly such that the top of channel 17 is narrower than the bottom.

FIG. 2D illustrates another example of a configuration of channel 16. Asshown in FIG. 2D, side walls 16 b and 16 c perpendicularly extend frombottom surface 16 a. Like first channel 16, second channel 17 can alsobe configured such that side walls 17 b and 17 c perpendicularly extendfrom bottom wall 17 a. In some embodiments, side walls 16 b, 16 c and 17b, 17 c include internal extending rails 16 d, 17 d that perpendicularlyextend inwardly from side walls 16 b, 16 c and 17 b, 17 c, respectively.

Regardless of the configuration of channels 16 and 17, either firstchannel 16 or second channel 17 faces away from the ankle and willengage with rotation guide pointer 30 as described in greater detailbelow. This configuration enables rotation guide slide 20 to be usedduring an ankle replacement procedure for either the right ankle or leftankle.

FIGS. 3A and 3B are isometric views of one example of a rotation guidepointer 30 in accordance with some embodiment, and FIG. 3C is a sideprofile view rotation guide pointer 30. Rotation guide pointer 30comprises a wide, rectangular base 22 and a narrow, elongated pointerextension 24 that extends from base 22. As best seen in FIG. 3C, theunderside 21 of base 22 includes a protrusion 26 configured to engagefirst channel 16 or second channel 17 of rotation guide slide 20.Protrusion 26 extends longitudinally across base 22 (i.e., in adirection that is perpendicular with respect to the longitudinal lengthof elongated pointer extension 24). As best seen in FIG. 3C and has aflat bottom surface 26 a and angled sides 26 b and 26 c such that thetop portion of protrusion 26 is narrower than the bottom surface suchthat protrusion 26 has a complementary shape to channels 16 and 17 ofrotation guide slide 20. In some embodiments, sides 26 b and 26 c ofprotrusion 26 perpendicularly extend from bottom surface 26 a ofprotrusion 26.

Referring again to FIG. 3A, the top side 25 of base 22 includes a fingertab 27 extending perpendicularly from the top side 25 of base 22 andrunning along a lateral axis perpendicular to the longitudinal axis ofprotrusion 26. Put another way, finger tab 27 extends from top side 25and extends parallel to the longitudinal direction of the elongatedpointer extension 24. Finger tab 27 can be used to approximately alignpointer extension 24 with the mechanical axis of the tibia 260 asdescribed in greater detail below.

Still referring to FIG. 3A, top side 25 of base 22 defines a pair ofscrew holes 36, with one hole being located on either side of finger tab27. Each screw hole 36 is configured to receive a screw 37 (FIG. 4A) toaffix rotation guide pointer 30 to rotation guide slide 20. In someembodiments, screw 37 extends through protrusion 26, exiting bottomsurface 26 a and penetrating bottom surface 16 a on the rotation guideslide 20. In other embodiments, screws 37 do not exit the rotation guidepointer 30; rather, screws 37 are configured to expand side walls 26 band 26 c, causing protrusion 26 to expand within channel 16 and creatinga friction connection between rotation guide pointer and rotation guideslide.

Pointer extension 24 extends from base 22 at a first end 31 and tapersat a second end 32 to form a rounded point 33. Pointer extension 24defines a pin hole 28 along its length that extends from a top side 34to a bottom side 35. The pin hole 28 is positioned at a distance fromthe base 22 that is sufficient to allow the appropriate travel of othercomponents, e.g., adjustment block 100, which is described in greaterdetail below.

The use of rotation guide assembly 40 is now briefly described withreference to FIGS. 4A and 4B, which is used once access is gained to thetibia 260 and talus 265. In some embodiments, such access is gained bymaking an anterior incision lateral of the tibialis, with care taken toavoid the anterior tendons, to expose the tibia 260, talus 265, and aportion of the midfoot. In some embodiments, the incision isapproximately 125 mm long; however, one of ordinary skill in the artwill understand that the incision can be greater or less than 125 mm.

Gutter fork 10 is inserted into the medial gutter of the ankle joint,and rotation guide slide 20 is operationally connected to medial gutterfork 10 by placing guide hole 18 over shaft 2 as illustrated in FIG. 4A.Rotation guide slide 20 is positioned with either first channel 16 orsecond channel 17 facing away from the tibia 260. Rotation guide pointer30 is operationally connected to rotation guide slide 20 by slidingprotrusion 26 into either first channel 16 or second channel 17,whichever is facing away from the tibia 260. Thus assembled, an operatoruses finger tab 27 to rotate the combined rotation guide slide 20 androtation guide pointer 30 about an axis defined by shaft 2. A surgeon orother profession can also use finger tab 27 to slide rotation guidepointer 30 along an axis defined by first channel 16 or second channel17. The operator thus uses finger tab 27 to rotate the combined rotationguide slide 20 and rotation guide pointer 30 and slide rotation guidepointer 30 until pointer extension 24 is approximately aligned with themechanical axis of the tibia 260.

The position of rotation guide slide 20 can be fixed relative to gutterfork 10 by inserting a set screw (not shown) into hole 19 defined byrotation guide slide 20, and the position of the rotation guide pointer30 relative to the rotation guide slide 20 can be fixed by tighteningscrews 37. A first guide pin 50 is inserted through pin hole 28 and intothe tibia either percutaneously or directly into the tibial shaft. Withfirst guide pin 50 thus inserted, the entire rotation guide assembly 40is removed, leaving first guide pin 50 in place. FIG. 5 is an isometricview of a tibia 260 with first guide pin 50 inserted and the rotationguide assembly 40 removed.

In some embodiments, the placement of guide 50 is accomplished usingpatient-specific guides. Examples of such patient-specific guides andmethods of making such patient-specific guides are described in commonlyassigned U.S. patent application Ser. No. 12/711,307, entitled “Methodfor Forming a Patient Specific Surgical Guide Mount, U.S. patentapplication Ser. No. 13/330,091, entitled “Orthopedic Surgical Guide,”and U.S. patent application Ser. No. 13/464,175, entitled “OrthopedicSurgical Guide,” the entireties of which are incorporated by referenceherein. A conversion instrument for interfacing with patient specificguides is described in greater detail below.

Alignment Frame Assembly and Related Components

FIGS. 6 and 7 illustrate one example of an alignment frame assembly 140in accordance with some embodiments. Alignment frame assembly 140 can beused to place pins 150 (FIG. 28) in a patient's tibial. In someembodiments, alignment frame 140 includes a proximal alignment frame 109as illustrated in FIG. 6 and a distal alignment frame 105 as illustratedin FIG. 7.

Referring first to FIG. 6, proximal alignment frame sub-assembly 109includes an elongate body with a first end 102 and a second end 104. Insome embodiments, proximal alignment frame 109 includes two knobs 106,108 at end 102. Knob 106 can be selectively loosened and tightened toallow for coronal rotation adjustment and for locking the adjustment ofthe angle between an axis defined by the end 102 and an axis defined bythe end 104 by locking the proximal end 102 at a particular locationalong perpendicular slot 101 for coronal rotation adjustment. Knob 108allows for sagittal rotation adjustment and connecting end 102 to aproximal tibial pin 154, which is received within hole 103, or to a kneebracket 142 as described in greater detail below. Hinge 137 allows forend 102 to pivot relative to end 104.

Turning now to FIG. 7, distal alignment frame sub-assembly 105 extendsbetween a first end 107 and a second end 124. At end 107, the distalalignment frame 105 includes an elongate body 126 defining a centralchannel 126 a, which extends the length of body 126 and is configured toreceive end 104 of the proximal alignment frame 109 therein. A knob 128is provided at end 107 and is configured to allow adjustment andfixation of the length of the proximal alignment frame 109. For example,knob 128 can be loosened to enable end 104 of proximal alignment frame109 to be slid within channel 126 a, and knob 128 can be tightened toprevent relative movement between proximal alignment frame 109 anddistal alignment frame subassembly 105.

At end 124, the distal alignment frame 105 includes a rectangular bodyor structure 190 defining a plurality of holes 132. Holes 132 extendfrom a top surface 191 to a bottom surface 193 of structure 190 and aresized and configured to receive pin sleeves 176 (FIG. 24A) forinstalling pins 150 into the tibia 260. Although six holes 132 are shownin FIG. 7, fewer or more holes are provided in some embodiments. Asdescribed in greater detail below, pins 150 are inserted into the tibia260 and are used for positioning other devices during a total anklereplacement surgery in accordance with some embodiments.

Still referring to FIG. 7, a hole 194 is defined in a structure 195,which is disposed in a distal-most portion of distal alignment frame105. Structure 195 is hingedly connected to rectangular structure 190and is sized and configured to receive a guide pin 50 within hole 194,which is inserted into the tibia 260 using rotation guide assembly 40 asdescribed above. A knob 196 is configured to lock frame 105 to pin 50received within hole 194.

As best seen in FIG. 17, structure 190 defines a longitudinal slot 138that extends parallel to the longitudinal direction of distal alignmentframe 105 (i.e., in a distal to proximal direction). Longitudinal slot138 is configured to receive a shaft of an angel wing alignment guide160. Structure 190 also defines a hole 139 that extends from top surface191 and intersects slot 138. Hole 139 is configured to receive a setscrew (not shown) to secure the angel wing alignment guide 160 in placeas described in greater detail below.

FIG. 8 illustrates one example of a knee bracket 142 in accordance withsome embodiments. Knee bracket 142 includes a base 144 that is curved tobe positioned over the proximal end of the tibia 260 and a post 146configured to be received within the hole 103 of the proximal end 102 ofthe proximal alignment frame 109. A hook 152 extends from an uppersurface of each end of knee bracket 142. Hooks 152 are provided tosecure a strap, such as strap 148 illustrated in FIG. 9, to knee bracket142. In some embodiments, strap 148 is formed from rubber, but strap 148can be provided from other materials as will be understood by one ofordinary skill in the art. Strap 148 defines a plurality of holes 150that are sized and configured to receive hooks 152 of knee bracket 142.

FIG. 10 is an isometric view of one example of an angel wing alignmentguide 160 in accordance with some embodiments. Angel wing alignmentguide 160 includes a hippocrepiform base 162 defining a plurality ofholes 164 at both ends. A post 166 extends perpendicularly from the base162 and is configured to be received within the slot 138 at end 124 ofthe distal alignment frame 105 as best seen in FIG. 17. Holes 164 aresized and configured to receive an alignment rod, such as alignment rod170 illustrated in FIG. 11. In some embodiments, alignment rod 170 hasan elongate body that includes a stop collar 172 disposed along itslength to divide alignment rod 170 into unequal portions 170A and 170B.As shown in FIG. 11, portion 170A is shorter than portion 170B.

The installation of alignment frame assembly 140 is described brieflywith reference to FIGS. 12-28. FIG. 12 illustrates one example ofalignment frame assembly 140 in its assembled form. In some embodiments,alignment frame assembly 140 is assembled by inserting end 104 of theproximal alignment frame 109 into end 107 of distal alignment frame 105.Alignment frame assembly 140 is connected to the tibia by sliding thehole 194 at end 124 of the distal alignment frame 105 over the firstguide pin 50 that is positioned in tibia 260 as shown in FIG. 12. A pin154 is installed percutaneously through the hole 103 at the proximal end102 of the proximal alignment frame 109 into a tibial tuberosity.

Alternatively, as shown in FIGS. 13A-13C, the knee bracket 142 andrubber strap 148 can be used to secure the alignment frame assembly 140to the proximal end of the tibia 260. For example, knee bracket post 146is inserted into the hole 103 defined at end 102 of the proximalalignment frame 109 such that knee bracket base 144 is positioned overthe proximal end of the tibia 260. Rubber strap 148 is used to securethe patient's leg to knee bracket 142. For example, rubber strap 148 iswrapped laterally around the tibia 260, and hooks 152 of the kneebracket base 144 are inserted into the holes 151 of the rubber strap148.

The distal end 124 of the distal alignment frame 105 is placed above thetibia such that a gap, G, is provided between the distal alignment frame105 and the tibia as shown in FIG. 14. In some embodiments, the gap isapproximately 20-25 mm from the frame 105 to the tibia 260; however,gap, G, can have other dimensions that are greater than or less than20-25 mm. Once the desired gap is achieved, distal knob 196 is turned tolock the distal end 124 of the distal alignment frame 105 to the firstguide pin 50, as illustrated in FIG. 14.

As described above, the proximal alignment frame 109 is adjustable inlength and can be fixed at a particular length by turning knob 128 ofthe distal alignment frame 105 as shown in FIG. 18. First knob 106 atthe proximal end 102 of the proximal alignment frame 109 can be turnedas indicated by arrow A2 to allow adjustment of the angle of aperpendicular slot 101 at the proximal end 102 of the proximal alignmentframe 109 for coronal rotation adjustment as indicated by arrows A3 andA4. As shown in FIGS. 15 and 16, knob 108 of the proximal alignmentframe 109 is turned as indicated by arrow A1 to lock the alignment frameassembly 140 to the pin 154 and/or knee bracket post 146.

FIG. 17 is an isometric view of the angel wing alignment guide 160attached to the distal end 124 of the distal alignment frame 105, whichis connected to the tibia via the first guide pin 50. In someembodiments, the angel wing alignment guide 160 is attached to thealignment frame assembly 140 by inserting the angel wing alignment guidepost 166 into the slot 138 at the distal end 124 of the distal alignmentframe 105. A set screw (not shown) is inserted through hole 139 thatintersects the slot 138 and secured with a hex driver 174 (FIG. 19). Theset screw (not shown) can be loosened to allow proximal/distaladjustment of the angel wing alignment guide 160. In some embodiments,the position of the angel wing alignment guide 160 is viewed under A/Pfluoroscopy to establish coronal alignment, which is typically parallelto the natural joint line, as illustrated in FIG. 20.

As illustrated in FIG. 21, the portion 170B of alignment rod 170 isinserted through one of the holes 164 in either side of the angel wingalignment guide base 162, and alignment rod 170 is inserted into one ofthe holes 164 until stop collar 172 abuts angle wing alignment guidebase 162. Second knob 108 and/or the distal knob 196 of the alignmentframe assembly 140 can be turned to allow sagittal rotation adjustment,as illustrated in FIG. 22. The position of the alignment rod 170 can beviewed under lateral fluoroscopy to establish sagittal rotation, whichis typically parallel to a shaft of the tibia 260, as illustrated inFIG. 23.

After the adjustments are made, the angel wing alignment guide 160 andalignment rod 170 are removed. As illustrated in FIGS. 24A and 25, pinsleeves 176 are inserted into a pair of aligned holes 132 of theplurality of holes 132 at the distal end 124 of the distal alignmentframe 105 that provide the optimal bone purchase. As illustrated in FIG.25, this position is shown as the two center holes 132 in the superiorand inferior rows of holes; however, the optimal bone purchase positioncould be the medial or lateral holes 132. A trocar, such as trocar 178illustrated in FIG. 24B, is inserted into each of the pin sleeves 176 tocreate “stab wounds” for percutaneous pins, as illustrated in FIG. 26.The trocar 178 is then removed.

As illustrated in FIG. 27, a pin 150 is inserted into each of the pinsleeves 176 and through both cortices of the tibia 260, which is usedfor positioning of other structures of the total ankle replacementsystem as described in greater detail below. Once the pins 150 areplaced, the pin sleeves 176 are removed and the second knob 108 anddistal knob 196 are loosened to remove the alignment frame assembly 140.The proximal tibial pin 154 or knee bracket 142 and the first guide pin50 are then removed, leaving pins 150 in the tibia 260, as illustratedin FIG. 28.

Position Adjustment Guide and Related Components

FIG. 29 is an isometric diagram of a position adjustment device 100(also referred to below as an “adjustment block”) for positioning ofdrilling and cutting tools for tibia resectioning and for tibia trialinsertion in accordance with some embodiments. Adjustment block 100provides a common reference location for locating tools and the tibiatrial components throughout sizing, resectioning, and trialingprocedures. In some embodiments, the adjustment block 100 is smallenough in profile to position a cut guide into the wound space close tothe tibia bone without applying excess skin tension. The physician canuse the adjustment block to position a drill guide and/or cut guidecloser to the tibia bone, to make more accurate cuts with less chance ofthe blade or pins flexing.

The adjustment block 100 has three independently positionable frames110, 120, and 130 for precisely positioning a tool holder 134 adjacentthe joint to be replaced.

The first frame 110 is configured to be attached to two fixation pins150, which have been inserted in the anterior surface of the tibia, nearthe distal end of the tibia using the instrumentation as describedabove. A locking screw 112 actuates a locking plate (not shown), whichbears against the fixation pins 150 to secure the adjustment block 100relative to the pins. The first frame has a proximal-distal adjustmentknob 111 coaxially connected to a screw 113. The screw 113 can have anAcme thread, trapezoidal thread, square thread or other suitable threadfor leadscrew use. The second frame 120 is fixedly attached or unitarilyformed with a leadscrew nut (not shown), which the screw 113 drives.Rotation of the proximal-distal adjustment knob 111 rotates screw 113 toadvance or retract the second frame 120 in the proximal-distaldirection. When the second frame 120 is at the desired proximal-distalcoordinate, the physician advances the locking screw 114 to lock thesecond frame 120 to the first frame 110 in place.

The second frame 120 has at least one medial-lateral adjustment knob 121a, 121 b coaxially connected to a screw 123. The screw 123 can have anAcme thread, trapezoidal thread, square thread or other suitable threadfor leadscrew use. The screw 123 drives a leadscrew nut (not shown), towhich the third frame 130 is fixedly attached or unitarily formed.Rotation of the medial-lateral adjustment knob 121 a or 121 b rotatesscrew 123 to move the third frame 130 in the medial-lateral direction.When the third frame 130 is at the desired medial-lateral coordinate,the physician advances the locking screw 122 to lock the leadscrew 123of the second frame 120 in place.

The third frame 130 has an anterior-posterior adjustment knob 131coaxially connected to a screw 133. The screw 133 can have an Acmethread, trapezoidal thread, square thread or other suitable thread forleadscrew use. The screw 133 drives a leadscrew nut 136, to which a toolholder 134 is fixedly attached or with which tool holder 134 isunitarily formed. Rotation of the anterior-posterior adjustment knob 131rotates screw 133 to move the tool holder 134 in the anterior-posteriordirection. The tool holder 134 is adapted to hold a drilling tool, acutting tool, or a tibia trial 210.

FIG. 30 is an exploded view showing the adjustment block 100, tibiatrial 210, poly trial insert 230, and floating trial 250. FIG. 31 is anisometric view of the tibia trial 210. FIG. 32 is an anterior (front)elevation view of the tibia trial 210. FIG. 33 is a sagittal (side)elevation view of the tibia trial 210.

The tibia trial 210 provides the profile of the tibia tray portion of anankle replacement system. The tibia trial 210 comprises a plate 211 witha top surface adapted to fit against a distal surface 262 of theresectioned tibia 260 (FIG. 41). The plate 211 has a plurality of holes212 (FIG. 31) to be used to locate peg holes 263 in the resectionedtibia 260 (FIG. 41). The plate 211 has a bottom surface 216 including achannel adapted to receive a trial insert, such as a poly trial insert230. An anterior tibia reference member 218 extends from the plate 211as best seen in FIG. 33. The anterior tibia reference member 218 has aposterior surface 219 adapted to contact an anterior surface 261 of thetibia 260 (FIG. 41) when the tibia trial 210 is positioned properly. Thetibia trial 210 has an anterior mounting portion 213, which definesholes 214, that is sized and shaped to be mounted to the tool holder 134of the adjustment block 100. In some embodiments, the tibia trial 210has a notch 217 for aligning an anterior surface of the poly trialinsert 230 with the tibia trial 210. Alignment (or misalignment isreadily visible by checking whether the notch 217 is aligned with anedge of the poly trial insert 230). In some embodiments, the tibia trial210 is formed of a strong, corrosion resistant material such asstainless steel or a titanium alloy.

Referring again to FIG. 30, poly trial insert 230 is configured toprovide the profile of the poly insert of an ankle replacement system.The poly trial insert 230 comprises a top surface 231 adapted to bedetachably mounted to the bottom surface 216 of the plate 211 of thetibia trial 210 (FIG. 31). The poly insert 230 has a concave bottomsurface 232 with a size and shape of a prosthetic tibia joint surface ofthe ankle replacement system. The thickness of the poly trial insert 230matches the poly insert of the ankle replacement system to which thepoly trial insert 230 corresponds, allowing verification of the size andthickness of the poly insert using the poly trial insert 230. In someembodiments, the poly insert of the ankle replacement system has alocking tab to prevent release from the talar tray after surgery; butthe poly trial insert 230 has a non-locking tab 233 with a rampedsurface, to be detachably inserted in the tibia trial 210 and removedafter sizing and resectioning is completed. The non-locking tab 233 fitsin a corresponding recess (not shown) in the bottom surface 216 of thetibia trial 210. The posterior end of the poly trial insert 230 has anundercut 234. In some embodiments, the poly trial insert 230 is madefrom the same type of material used in the poly insert of an anklereplacement system. In some embodiments, the poly trial insert 230 ismade of a chemical-resistant material such as polyphenylsulfone, whichis also referred to as RadelR.

FIG. 34 is an isometric view of the floating trial 250. The floatingtrial 250 is configured to provide a contour that matches the contour ofthe talar dome of the ankle replacement system, which is described ingreater detail below. The floating trial 250 is configured to beinserted beneath the poly trial insert 230 to contact the concave bottomsurface 232 of insert 230. The floating trial 250 comprises a member 251having at least one convex anterior surface with a size and shape of aprosthetic talar dome of the ankle replacement system, to permitarticulation with the concave surface 232 of the insert. The posteriorsurface 255 of the member 251 is shaped to match the contour of theresectioned talus. In some embodiments, the floating trial 250 has twoconvex surfaces 251 as shown in FIG. 34. The floating trial 250 furtherincludes a handle portion 252, which is sized to project from theresection site, so the physician can easily optimize the position of thefloating trial for smooth articulation with the poly trial insert 230.The handle 252 of the floating trial 250 has a plurality of pin holes253 for receiving fixation pins to be used for locating a talar cutguide (not shown). Once the position is optimized, the pins are insertedthrough the pin holes 253 before completing the resectioning of thetalus. In some embodiments, the floating trial 250 is formed of astrong, corrosion resistant material such as stainless steel or atitanium alloy. In some embodiments, the floating trial 250 also has oneor more anterior chamfers 254 for reference and alignment.

FIGS. 35-45 show various stages of a method of resectioning andtrialing, using the adjustment block 100, optional drill guide 280,optional cut guide 290, tibia trial 210, poly trial insert 230 andfloating trial 250. This is one example of a use of the devices, but isnot limiting.

FIG. 35 shows the adjustment block 100 fixed to the fixation pins 150(e.g., 3.2 mm pins), which have been inserted in the anterior surface ofthe tibia 260 near the distal end 261 of the tibia (not shown). Alsoshown in FIG. 35 is a drill guide 280 attached to the tool holder 134 ofthe adjustment block 100, with the first frame 110 slightly above theanterior surface of the tibia 260. In some embodiments, the tool holder134 includes a stage with a pair of pins 135, and the drill guide 280has a corresponding pair of mounting ears 283 with holes adapted to snaponto the pins 135. This tool holder design is just exemplary in nature,and other embodiments include other suitable mounting structures asdescribed in greater detail below.

In the embodiment of FIG. 35, the drill guide 280 is a small profiledevice sized and shaped to be inserted beneath the refracted skin (notshown) in the ankle region. The drill guide 280 has at least two guideholes 281 to be used to drill pilot holes in the tibia 260. The drillguide also has pin holes 282 that can be used to pin the drill guide tothe bone, for position fixation. In some embodiments, the drill guide280 has sizing patterns 285 showing the size and location of one or moreresectioning cuts corresponding to the holes to be drilled using thedrill guide 280. In some embodiments, the drill guide 280 has one ormore reference lines 286 that the physician optionally can use toposition the drill guide 280 (by adjusting the proximal-distal knob 111,the medial-lateral knob 121 a or 121 b, and the anterior-posterior knob.In some embodiments, the lines 285, 286 are visible under a fluoroscope,so the physician can view the position and size of the lines 285, 286 insitu, relative to the patient's bones.

The physician sizes the tibial tray component of the ankle replacementsystem by mounting a drill guide 280 on the tool holder and adjustingits position as described above. The position adjustment device(adjustment block) 100 is locked with the tool holder 134 at firstcoordinates in the proximal-distal and medial-lateral directions.

The physician views the X-ray of the tibia bone 260 and drill guide 280and determines whether it is the optimum size and position for thepatient. The position can be adjusted based on the X-ray, using knobs111, 121, 131. If the size of the resectioning cut corresponding to thedrill guide 280 is too large or too small, the physician removes thedrill guide, selects a different size drill guide, and snaps the newdrill guide onto the tool holder 134 of the adjustment block 100. Thedrill guide is then repositioned against the tibia, imaged byfluoroscope, and the size is again checked. To facilitate fluoroscopicX-ray imaging, the drill guide 280 can be made of plastic, while thecircles surrounding holes 281 and the patterns 285, 286 can be made ofmetal. Thus, only the circles surrounding holes 281 and the patterns285, 286 appear on the X-ray, superimposed against the tibia 260 andtalus 265.

Although some embodiments use a single drill guide 280 for sizing,location of fixation pins by holes 282 and drilling corners 281, otherembodiments described below use a first guide with holes 282 andpatterns 285, 286 for sizing the tibia trial 210 and locating thefixation pins, and a second guide (e.g., a drilling guide) with holes281 and 282 for performing the drilling. Because the adjustment block100 and the pins in holes 282 provide common references, the holes 281can still be drilled with proper location relative to the pin holes 282and patterns 285, 286.

FIG. 36 shows the tibia 260 with adjustment block 100 and drill guide280. Soft tissue is omitted for ease of viewing. When the physician hasverified that the optimum size of drill guide 280 has been selected, thephysician pins the drill guide 280 to the tibia 260 using (e.g., 2.4 mm)fixation pins 287 inserted through the pin holes 282 and trimmed suchthat pins 287 extend slightly above the drill guide 280. Then thephysician drills holes in the tibia 260 through the guides holes 281using the drill guide 280 and drill 288. The holes thus drilled in thebone 260 define corners of a resectioning cut to be performed in thetibia. The physician then removes the drill guide 280, while leaving thepins 287 in place (in the distal portion of the tibia 260 to be removedby the resectioning). While removing the drill guide 280, the adjustmentblock can remain locked in the first coordinates with the first frame110 adjusted to the same proximal-distal coordinate and the second frame120 adjusted to the same medial-lateral coordinate.

FIG. 37 shows the adjustment block 100 still fixed to the fixation pins150 in the same position, with a cut guide 290 mounted to the toolholder 134 of the adjustment block 100. The cut guide 290 has aplurality of slots 295, sized and located to connect the corner holesdrilled with the drill guide 280. The cut guide 290 is sized and shapedto match the drill guide 280. Thus, the physician has a set of drillguides 280 and a corresponding set of cut guides 290. The selection of adrill guide size automatically selects the corresponding cut guide sizeto make cuts which are sized and located to connect the corner holesdrilled with the drill guide 280, as described above. The cut guide 290has a corresponding pair of mounting ears 293 with holes adapted to snaponto the pins 135. The cut guide 290 also has pin holes 292 which aresized and located to receive the fixation pins 287. This aligns theposition of the cut guide 290 with the position previously occupied bythe drill guide 280, to ensure alignment of the resectioning cuts withthe previously drilled corner holes. In some embodiments, the cut guide290 includes additional ears 296 with pin holes for receiving additionalfixation pins 297.

To mount the cut guide 290, the physician slides the holes 292 of cutguide 290 over the fixation pins 287 and snaps the cut guide into placeon the tool holder 134. For stability, the physician can then insert twomore fixation pins 297 through the pin holes of ears 296 and into thetalus bone 265. With the cut guide 290 securely pinned to bones 260,265, the physician performs the resectioning cuts through the guideslots 295, cutting the bone to connect the previously drilled holes. Insome embodiments, such as the embodiment illustrated in FIG. 37, one cutguide 290 is used for both the tibia resection and the first cut of thetalar resection. The cut guide 290 is then removed from the surgerysite, and detached from the adjustment block 100. The sections of thetibia 260 and talus 265 that have been cut are removed, along with thefixation pins 287 and 297. In other embodiments (not shown), the tibiacut guide is only used to resection the tibia, and a separate cut guideis used to resection the talus after removal of the tibia cut guide.

The use of the adjustment block 100 permits the holes 281 to be drilledfirst with a first tool, and the cuts to be performed afterwards with asecond tool, while maintaining accurate alignment between the holes andthe cuts. Drilling the holes first avoids stress concentrations at thecorners of the resectioned distal tibia.

Although some embodiments described herein use a drill guide 280 and acut guide 290 commonly fixed using the adjustment block 100 and fixationpins 287, other embodiments attach different tools to the tool holder134 for purpose of resectioning the tibia and talus. For example, someembodiments include a cut guide without using a separate drill guide.

Following the initial resectioning of tibia 260, which is described ingreater detail below, the physician inserts the tibia trial 210, polytrial insert 230 and floating trial 250, while the adjustment block 100is still locked to the two fixation pins 150, and the tool holder 134 isin the first coordinates in the proximal-distal and medial-lateraldirections. Should the physician choose to temporarily remove theadjustment block from the surgery site (e.g., for inspection, cleaningor suctioning), the physician returns the adjustment block to the samecoordinates to locate the tool holder 134 at the same position tocomplete the procedure. Because the fixation pins 150 are excluded fromthe distal portion of the tibia removed by the resection, the fixationpins 150 are available throughout the procedure for use in adjusting orcorrecting the resection cuts.

The physician snaps the tibia trial 210 onto the tool holder 134. FIGS.38 and 39 show the adjustment block in position with the tibia trial 210attached. The adjustment block 100 is adjusted to position the toolholder in an anterior-posterior direction, while the tool holder is atthe first coordinates in the proximal-distal and medial-lateraldirections. The tibia trial 210 is repositioned in the posteriordirection until a predetermined portion of the tibia trail contacts ananterior cortex of the tibia. In some embodiments, the position of thethird frame 130 is adjusted until the posterior surface 219 of anteriortibia reference member 218 extending from the plate 211 contacts theanterior cortex of the tibia 260.

In some embodiments, the tibial trial 210 is used in connection with aspacer 240 to assess the ligament laxity of the ankle joint as shown inFIGS. 39A and 39B. Spacer 240 can be provided in a variety ofthicknesses including, but not limited to 4 mm, 5 mm, and 6 mm to listonly a few possibilities. As shown in FIGS. 33A and 33B, spacer 240includes an elongate body 242 including an extension 244 at one end.Extension 244 defines spaced apart holes 246 that are sized andconfigured to receive fixation pins 297 therein. A blind hole 248 thatis at least partially threaded is also defined by spacer 240 and isconfigured for aiding the removal of spacer 240 from its engagement withtibial trial 210. In some embodiments, spacer 240 is fabricated from aradiolucent material.

Once tibia 260 is resectioned using the superior and angled medial andlateral slots of cutting guide 290 shown in FIG. 37, the resectedportion of the tibia 260 is removed. Tibia trial 210 is inserted asdescribed above, and spacer 240 is inserted into engagement with tibiatrial 210 as shown in FIGS. 39A and 39B. The combination of tibia trial210 and spacer 240 are used to assess the ligament laxity prior toresection of the upper talus. Once the ligament laxity has beenassessed, spacer 240 can be removed and cutting guide 290 can be placedback over pins 297 and the inferior slot can be used to resect to thetop of talus 265 as shown in FIG. 39C.

In some embodiments, an additional talar cutting guide, such as talarcutting guide 270 illustrated in FIGS. 39D and 39E, can be used toprovide an initial talar resection or to further resect the talus beyondthe resection provided by cutting guide 290. As shown in FIGS. 39D and39E, illustrate one example of a cutting guide 270 coupled to a resectedtalus 265 by fixation pins 297, which are disposed within distal holes272. A set of proximal holes 274, which are offset from distal holes272, and an elongate cutting slot 276 slot also are defined by cuttingguide 270. As can be seen by comparing FIGS. 39D and 39E, proximal holes274 are offset from distal holes 272 by a distance to provide a surgeonwith the options of resecting different amounts of the talus bone. Insome embodiments, the vertical difference between the position of holes272 and holes 274 is 2 mm. However, one of ordinary skill in the artwill understand that the vertical distance between the center of holes272 and 274 can be greater or less than 2 mm.

FIG. 40 shows the tibia 260 and talus 265 with the tibia trial 210 inposition. The tibia peg drill (not shown) is placed in the head of atibia peg drill guide 299, and is inserted in the holes 212 (FIG. 31) ofthe tibia trial 210. The physician drills a plurality (e.g., 3) pegholes 263 in the distal surface 262 of the resectioned tibia 260 usingthe tibia peg drill 299. The holes 212 (FIG. 31) of the tibia trial 210are used to locate these holes 263. FIG. 41 shows the distal end 261 ofthe tibia 260 at the completion of the peg drilling, with the three pegholes 263 in the resectioned surface 262 of the tibia.

The tibia trial 210 is used to verify size and shape of the resectioningusing the tibia trial, prior to implanting the ankle replacement system.Advantageously, the steps of attaching the tibia trial 210 to the toolholder 134, adjusting the position adjustment device 100 to position thetool holder 134 in an anterior-posterior direction, and placing thetibia trial 210 on the resectioned tibia 260 using the tool holder 134,can be formed without inserting any additional location fixing pins intothe tibia, while the tool holder is locked in the first coordinates inthe proximal-distal and medial-lateral directions.

FIGS. 42 and 43 show the adjustment block 100 and tibia trial 210, afterinstalling the poly trial insert 230 into the tibia trial 210 andpositioning the floating trial 250 between the talus 265 and the polyinsert trial 230, to permit articulation with the concave surface 232 ofthe poly insert trial 230 while the tool holder is in the firstcoordinates in the proximal-distal and medial-lateral directions. Thephysician can now assess the fit of the ankle replacement system,including size, anterior-posterior position, and whether the tibia hasbeen sized, drilled and cut optimally. If any adjustments are deemedappropriate to the tibia resectioning, the physician can reapply the cutguide with the adjustment block set to the same proximal-distal andmedial-lateral coordinates used before.

Referring to FIGS. 44 and 45, the physician now performs a trialreduction to ensure the correct poly insert height and talus domeposition. The talar implant anterior-posterior coordinate is determinedby moving the floating trial 250 to the location where it bestarticulates with the concave surface 232 of the poly trial insert 230.Two additional fixation pins 298 are inserted through the pin holes 253of the floating trial 250 using a K-wire, such as a 2 mm K-wire, forexample. Additional resection guides, described in greater detail belowcan be positioned by sliding pin holes in the resection guide(s) overthe fixation pins 298. The remaining talar cuts are then performed tomatch the geometry of the talar dome implant of the ankle replacementsystem as described below.

A position adjustment device (or adjustment block) 100 as describedabove provides a fixed point of reference that facilitates the APposition of the tibial and talar implants of an ankle replacementsystem. The adjustment block 100 is capable of fixing a tibial trial 210via a modular connection 134 to avoid insertion of additional pins inthe distal tibia. The tibial trial 210, while attached to the adjustmentblock 100, allows the user to set the tibial implant anterior-posteriorposition by abutting the anterior post 218 against the tibial bone. Thetibial trial 210 also serves as a drill guide to prepare the tibial pegson the tibial implant.

The tibial trial 210 while rigidly fixed to the adjustment block 100then translates the anterior-posterior position to the talar trial 250by using the poly trial insert 230 to articulate with the talar (dome)trial 250. The talar trial 250 also has chamfer indicators 254 to helpthe user determine the optimal talar anterior-posterior position.

Advantageously, the system and method described above uses theadjustment block 100 as a fixed reference to associate all otherinstruments used for trial sizing and trials related to tibial side ofthe ankle replacement. Thus, a tibial sizer (e.g., drill guide 280),tibial resection guide (e.g., cut guide 290), and tibial trial 210 canall be anchored at the same position defined by the adjustment block100. This method preserves the distal layer of the tibia to avoid excesspin holes from fixation pins and devices.

The compact size of the adjustment block allows the tools to be fixedand placed close to the surgery site, for more accurate cuts, withreduced chance of components flexing. Sizing guides (e.g., drill guide280) and resection guides (e.g. cut guide 290) can all be placed in thesurgical window. The position of the tools and trials can be accuratelyadjusted by turning the adjustment knobs 111, 121, 131 in a small area.

FIGS. 46 and 47 show another embodiment of the adjustment block 300configured with a tool holder 330. The adjustment block 300 has twoindependently positionable frames 110, 120 for precisely positioning atool holder 330 in the proximal-distal and medial-lateral directions,adjacent the joint to be replaced.

The first frame 110 is configured to be attached to two fixation pins150 which have been inserted in the anterior surface of the tibia, nearthe distal end of the tibia as described above. A locking screw 112actuates a locking plate (not shown), which bears against the fixationpins 150 to secure the adjustment block 100 relative to the pins. Thefirst frame has a proximal-distal adjustment knob 111 coaxiallyconnected to a screw 113. The screw 113 can have an Acme thread,trapezoidal thread, square thread or other suitable thread for leadscrewuse. The second frame 120 is fixedly attached or unitarily formed with aleadscrew nut (not shown), which the screw 113 drives. Rotation of theproximal-distal adjustment knob 111 rotates screw 113 to advance orretract the second frame 120 in the proximal-distal direction. When thesecond frame 120 is at the desired proximal-distal coordinate, thephysician advances the locking screw 114 to lock the second frame 120 tothe first frame 110 in place.

The second frame 120 has at least one medial-lateral adjustment knob 121a, 121 b coaxially connected to a screw 123. The screw 123 can have anAcme thread, trapezoidal thread, square thread or other suitable threadfor leadscrew use. The screw 123 drives a leadscrew nut (not shown), towhich the tool holder 330 is fixedly attached or unitarily formed with.Rotation of the medial-lateral adjustment knob 121 a or 121 b rotatesscrew 123 to move the tool holder 330 in the medial-lateral direction.When the tool holder 330 is at the desired medial-lateral coordinate,the physician advances the locking screw 122 to lock the leadscrew 123of the second frame 120 in place.

The position of the tool holder 330 in the anterior-posterior directionis determined by location of the first frame 110 relative to the pins150. The tool holder 330 can have any of a variety of configurations foreasily attaching a tool or trial. One example of a tool holder 330 isillustrated in FIG. 46. As shown in FIG. 46, tool holder 330 includes adovetail joint 332 and defines a cavity 334 between rails 336 ofdovetail joint 332. Tool holder 330 also defines a hole 338 extending ina direction parallel to the direction in which rails 336 of dovetailjoint 332 extend from a first side 340 to a second side 342.

Cavity 334 is sized and configured to receive a locking wedge 344therein. As best seen in FIG. 46, locking wedge 344 is cross-pinned incavity 334 by the combination of pins 346, 348, which are respectivelyreceived in holes 350, 352 (see also FIG. 52). For example, a pair ofpins 346 are received within holes 350, and a pin 348 is received withinhole 352. Locking wedge 344 includes a pair of spaced apart notches 354(FIG. 52) each being sized and configured to receive a biasing member356. Biasing members 356, which may take the form of compressionsprings, are disposed within notches 354 and urge locking wedge 344towards hole 338. A slot 358 (FIG. 52) is defined in locking wedge 344and is sized and configured to receive pin 348 (FIG. 46) therein toprevent locking wedge 344 from being separated from tool holder 330.

Referring again to FIG. 52, the upper surface 360 of locking wedge 344includes a pair of chamfered or angles 362, which facilitate engagementwith a locking screw 364 and the displacement and movement of lockingwedge 344 relative to tool holder 330. For example, hole 338 defined bytool holder 330 is sized and configured to receive locking screw 364 andis in communication with cavity 334 such that shoulders 366 and 368 oflocking screw 364 are in abutment with chamfers 362 of locking wedge344. In addition to shoulders 366, 368, locking screw includes anenlarged head 370 and threads or other engagement feature 372 at adistal end for engaging a corresponding structure defined by lockingwedge 344 for maintaining locking wedge 344 in a locked position suchthat locking wedge is pressed against biasing members 356 and engages atool disposed within dovetail joint 332. A pin 374 is disposed withinhole 376 defined by tool holder 330 at a position in which pin 374 isconfigured to contact shoulder 368 when locking screw 364 is in anunlocked position to maintain locking screw 364 in engagement with toolholder 330.

FIG. 47 illustrates an example of a coronal sizing and drill guide 380,which is similar to drill guide 280 described above, that is configuredto be mated to tool holder 330. One of ordinary skill in the art willunderstand that other tools (e.g., a cut guide) and trials (e.g., tibiatrial) can be adapted to fit the tool holder 330.

Coronal sizing and drill guide 380 includes corner drill holes 382,fixation holes 384, 386, sizing pattern 388, a slot 390, and a coronalparallax cue pin 392. Corner drill holes 382 are sized and configured toreceive a drill or reamer therein as described above and in greaterdetail below. Fixation holes 384, 386 are sized and configured toreceive a pin (e.g., fixation pin 297) therein for pinning the coronalsizing and drill guide 380 to the tibia and talus, respectively. Coronalsizing guide 380 can be formed from plastic or other material that istranslucent under a fluoroscope.

Slot 390 is sized and configured to receive a mating extension 412 of aguide arm 402 for supporting a sagittal sizing guide assembly 400 asshown in FIG. 48 and described in greater detail below. Sizing patterns388 have a shape that corresponds to the outer dimensions of a tibialimplant 1100 (FIG. 84) of an ankle replacement system and is formed froma material that is opaque under a fluoroscope. Examples of such materialinclude, but are not limited to, a metallic material. Still referring toFIG. 47, coronal parallax cue pin 392 is located in coronal sizing anddrill guide 380 provides for coronal parallax adjustment as it isaligned with a pair of pins (not shown) disposed on either side of cuepin 392.

Coronal sizing and drill guide 380 also includes a dovetail extension394 including a pair of opposed rails 396 which extend from an uppersurface 398 of coronal sizing and drill guide 380. Rails 396 are sizedand configured to be complementary to rails 336 of dovetail joint 332 oftool holder 330.

Adjustment block 100, tool holder 330, and drill guide 380 areconfigured to support a sagittal sizing guide assembly 400 asillustrated in FIGS. 48-56. As best seen FIG. 50, sagittal sizing guideassembly 400 includes a guide arm 402, a ratchet arm frame 420, and asagittal sizing guide body 460.

Turning now to FIGS. 48 and 49, guide arm 402 extends from a firstattachment end 404 to a second end 406, which is disposed at a distancefrom end 404. Attachment end 404 has an enlarged cross-sectional arearelative to the sliding area 408 such that one or more shoulders 410sized and configured to providing a stop for ratchet arm frame 420. Amating extension 412 extends from attachment end 404 and has an elongateshape that is sized and configured to be received within reference line286 (FIG. 35) defined by drill guide 280 described above. A secondextension 414 extends from attachment end 404 in a direction opposite ofmating extension 412 and provides an area for grasping or otherwisebeing manipulated. In some embodiments, extension 414 terminates atregion 416 having a cylindrical shape, although one of ordinary skill inthe art will understand that region 416 can have other geometric shapesto facilitate manipulation.

Sliding area 408 and second end 406 are elongate and have across-sectional shape that facilitates sliding while at the same timepreventing rotation by ratchet arm frame 420. In some embodiments, forexample, sliding area 408 and second end 406 have a trapezoidal crosssectional area such that ratchet arm frame 420 can slide along thelength of guide arm 402 without rotationally pivoting. One of ordinaryskill in the art will understand that sliding area 408 and second end406 can have other cross-sectional geometries.

Turning now to FIGS. 49-53, ratchet arm frame 420 defines an opening 422(FIGS. 49 and 52) sized and configured to receive sliding area 408 andsecond end 406 slidably therein as shown in FIG. 49. A second hole 424illustrated in FIG. 49 is defined by ratchet arm frame 420 orthogonal toopening 422 such that the second hole 424 intersects opening 422.Ratchet arm frame 420 also defines a blind opening 426 and one or morepin or screw holes 428. Blind opening 426 extends inwardly from the side430 that is disposed opposite the side 432 in which the second hole 424is defined as best seen in FIG. 53. One or more pin or screw holes 428inwardly extend from side 434 and intersect with blind opening 426.

A locking knob 436 is sized and configured to be received within opening422 and lock the position of ratchet arm frame 420 along the length ofguide arm 402. In some embodiments, locking knob 436 is biased by abiasing member (not show), such as a compression spring, such that anabutment portion (not shown) of locking knob engages and frictionallylocks a portion of the sliding area 408 of guide arm 402. Blind opening426 is sized and configured to receive a portion of a ratchet arm 442therein. As best seen in FIGS. 52-53, ratchet arm 442 includes aplurality of ridges 444 or notches along at least one side 446. Ratchetarm 442 is coupled to ratchet arm frame 420 by pins or screws 448 thatare received within pin or screw holes 428.

Referring now to FIG. 53, sagittal sizing guide body 460 is shown as arectangular cuboid defining a channel 462 that extends through thelength of sagittal sizing guide body 460 from a first side 464 to asecond side 466. A third side 468 defines a chamber 470 sized andconfigured to receive a biasing member 472 and push button 474 therein.Push button 474 defines a window 476 (FIGS. 50 and 52) that is sized andconfigured to receive ratchet arm 442 therein. The bottom ledge 478 ofwindow 476 (FIG. 52) has a width that is sized and configured to bereceived within the ridges 444 defined in the side 446 of ratchet arm442.

As shown in FIGS. 52 and 53, a dowel hole 480 inwardly extends from side466 and is sized and configured to receive a dowel 482 that is formedfrom a material that is opaque to fluoroscopy. Dowel hole 480 isdisposed at distance from side 484 of sagittal sizing guide body 460that corresponds to a location at which the tibia is resected, and dowelhole 480 has a length that corresponds to a length of tibial implant1100 of ankle replacement prosthesis 1000, which is described in greaterdetail below. Sagittal sizing guide body 460 also includes afluoro-opaque profile 486 having a size and shape that corresponds tothe profile of talar implant 1200 of ankle replacement prosthesis 1000.In some embodiments, the fluoro-opaque profile 486 is disposed within arecess defined by sagittal sizing guide body 460, and, in someembodiments, fluoro-opaque profile 486 is coupled to an exterior surfaceof sagittal sizing guide body 460 using an adhesive or mechanicalcoupling as will be understood by one of ordinary skill in the art.

The combination of dowel 482 and fluoro-opaque profile 486advantageously enable the sizing of a talar implant 1200 and theappropriate height of the talar resection to be check using fluoroscopyprior to resecting the talus. The resection height can be adjusted andlocked in by adjusting knob 111 of adjustment block 100. A number ofsagittal sizing guide bodies 460 can be available such that a surgeon orother health care professional can select the appropriate size based onthe actual anatomy of the patient. The differently sized sagittal sizingguide bodies 460 can be swapped for one another until the appropriatesagittal sizing guide body 460 is identified.

Talar Resection Guide and Related Components

FIGS. 55A-55F illustrate one example of a talar resection guide base2100 in accordance with some embodiments. The talar resection guide base2100 is configured for use as a base for an anterior talar pilot guide2130, which is illustrated in FIG. 56, and an anterior talar finishguide 2142, which is illustrated in FIG. 58, in resecting a talus 265.

Talar resection guide base 2100 defines a slot 2102 that extendstransversely across the base 2100. As described in greater detail below,slot 2102 is arranged and configured to align with the interconnectingholes 2132 defined by anterior talar pilot guide 2130 (FIG. 57) and slot2144 defined by the anterior talar finish guide 2142 (FIG. 59). Thetalar resection guide base 2100 also includes a plurality of holes2104-2110 each being sized and configured to receive a pin or othersurgical instrument therein. For example, two inferior holes 2104, 2106are defined on medial and lateral sides 2120, 2122 of lower flange 2101of the base 2100 that extends away from slot 2102. Holes 2104, 2106 areconfigured to receive fixation pins 298, and Inferior hole 2105, whichis defined between the two inferior holes 2104, 2106, is configured toreceive a pin 2155 (FIG. 62B).

Holes 2108, 2110 are defined on medial and lateral sides 2120, 2122 ofthe upper flange 2103 of base 2100, and each hole is configured toreceive a respective pin 2154, 2156 (FIG. 63) or other surgical device.Although there are five holes 2104-2110 configured to receive pinsdescribed, fewer or more holes are provided in some embodiments.

The talar resection guide base 2100 includes holes 2112-2118 disposednear the slot 2102. Holes 2112, 2114 are defined by upper flange 2103above the slot 2102, and holes 2116, 2118 are defined by lower flange2101 below the slot 2102. Slot 2102 includes a shoulder 2124 thatextends along the circumference of slot 2102. The superior side 2126 ofthe shoulder 2124 includes a narrow lateral slit 2128 extending parallelto the longitudinal axis of slot 2012 and being sized and configured toreceive a saw blade or bone saw therein. Slit 2128 is configured to aidin creating a posterior talar chamfer resection 2170 as described below.

Turning now to FIG. 56, an isometric view of one example of the anteriortalar pilot guide 2130 is illustrated in accordance with someembodiments. The anterior talar pilot guide 2130 includes a plurality ofinterconnecting holes 2132 a, 2132 b, 2132 c, 2132 d that cooperate todefine a slot 2132 that extends parallel to the longitudinal axis of theanterior talar pilot guide 2130. Each hole of slot 2132 is configured toreceive a talar reamer 2162 (FIGS. 66-67). The anterior talar pilotguide 2130 also includes pegs 2134, 2136 on its posterior side 2138.Each peg 2134, 2136 is sized and configured to be received in holes2112-2118 adjacent to slot 2102 of the talar resection guide base 2100such that the anterior talar pilot guide 2130 can be coupled to thetalar resection guide base 2100 as illustrated in FIG. 57. The anteriortalar pilot guide 2130 further includes an inferior tab 2140 for ease ofassembly and disassembly.

FIG. 58 is anisometric view of one example of the anterior talar finishguide 2142 in accordance with some embodiments. The anterior talarfinish guide 2142 includes a slot 2144 extending parallel to thelongitudinal axis of finish guide 2142. Slot 2144 is configured toreceive the talar reamer 2162 (FIGS. 66, 70-71). Anterior talar finishguide 2142 also includes pegs 2146, 2148, which extend inferiorly fromthe posterior side 2150 of finish guide 2142 and are configured to bereceived in holes 2112-2118 near the slot 2102 of the talar resectionguide base 2100 such that anterior talar finish guide 2142 can becoupled to talar resection guide base 2100 as shown in FIG. 59. Theanterior talar finish guide 2142 also includes an inferior tab 2152 forease of assembly and disassembly.

The use of the talar resection guide base 2100 in combination with theanterior talar pilot guide 2130 and anterior talar finish guide 2142 isdescribed with reference to FIGS. 60-74. FIG. 60 is an isometric view ofone example of the talar resection guide base 2100 attached to a talus265 via fixation pins 298 in accordance with some embodiments. The talarresection guide base 2100 is connected to a talus 265 by sliding theholes 2104, 2106 of the talar resection guide base 2100 over fixationpins 298, which can be previously installed having been guided using atalar dome trial device, such as floating trial 250 shown in FIG. 30 anddescribed above. In some embodiments, the talar resection guide base2100 is seated flush to the previously resected talar surface. Asillustrated in FIGS. 61 and 62A, temporary fixation screws or pins 2154,2156 are inserted into the two holes 2108, 2110 on either side of thebase 2100 using a T-handle pin driver 2158, which is illustrated in FIG.61. As illustrated in FIG. 62B, pin 2155 can be inserted throughinferior hole 2105 for additional stability. Pin 2155 can be cut flushto the surface of the talar resection guide base 2100 to preventinterference with any saw blades and reamers.

Turning now to FIGS. 63 and 64, an appropriately sized saw blade or bonesaw 2160 is inserted through the lateral slit 2128 in the shoulder 2124of the slot 2102 of the talar resection guide base 2100. The saw bladeor bone saw 2160 is used to resect the talus 265 to create the posteriortalar chamfer 2170, as best in FIG. 74. Once the area is resected, thesaw blade or bone saw 2160 is removed.

As illustrated in FIG. 65, the anterior talar pilot guide 2130 iscoupled to the talar resection guide base 2100 by inserting the pegs2134, 2136 of the anterior talar pilot guide 2130 into holes 2112, 2114located in the upper flange 2103 above the slot 2102 of the talarresection guide base 2100. An appropriate size talar reamer, such astalar reamer 2162 illustrated in FIG. 66, is used to make plunge cutsthrough the interconnecting holes that form slot 2132 of the anteriortalar pilot guide 2130. In some embodiments, the talar reamer 2162 has asolid elongate body 2164 with one end 2166 configured to be received inthe holes 2132 of the anterior talar pilot guide 2130 as a means to makeplunge cuts in the talus 265. The talar reamer 2162 includes a collar2168 on its end 2166 that serves as a stop for reaming depth.

Turning now to FIG. 67, plunge cuts are made to prepare the talarsurface for making an anterior chamfer 2172, which is best seen in FIG.74. Once the plunge cuts have been made, the anterior talar pilot guide2130 is removed from the talar resection guide base 2100 and is rotated180° as shown in FIG. 68. Pegs 2134, 2136 of the anterior talar pilotguide 2130 are inserted into two holes 2116, 2118 below the slot 2102 ofthe talar resection guide base 2100.

As illustrated in FIG. 69, the talar reamer 2160 is used to plunge cutthrough the interconnecting holes that collectively define slot 2132 ofthe anterior talar pilot guide 2130 to prepare the talar surface for ananterior flat 2174, which is best seen in FIG. 74. The anterior talarpilot guide 2130 is removed from the talar resection guide base 2100once the plunge cuts have been made.

FIG. 70 illustrates the anterior talar finish guide 2142 coupled totalar resection guide base 2100, which is accomplished by inserting thepegs 2146, 2148 of the anterior talar finish guide 2142 into two holes2112, 2114 defined in the upper flange 2103 of the talar resection guidebase 2100. With finish guide 2142 coupled to talar resection guide base2100, the talar reamer 2162 is used to perform the finishing cuts forthe anterior chamfer 2172 by sliding the talar reamer 2162 from side toside within the slot 2144 of the finish guide 2142, as indicated byarrow AR1 in FIG. 71. In some embodiments, the talar reamer 2162 ispositioned flush against the anterior talar finish guide 2142 for eachreaming step to ensure that the bone cuts are at the proper depth.

Once the finishing cuts for the anterior chamfer 2172 have been made,the anterior talar finish guide 2142 is removed from the talar resectionguide base 2100 and is rotated 180° as illustrated in FIG. 72. The pegs2146, 2148 of the anterior talar finish guide 2142 are inserted intoholes 2116, 2118 defined by the lower flange 2101 of the talar resectionguide base 2100. As shown in FIG. 73, the talar reamer 2162 is used toperform the finishing cuts for the anterior talar flat 2174 by slidingthe talar reamer 2162 from side to side within the slot 2144 of thefinish guide 2142, as indicated by arrow AR2. FIG. 74 illustrates thetalus 265 once the anterior talar finish guide 2142, talar resectionguide base 2100, and pins 2154, 2156 have been removed. The edges of theresidual bone can be cleaned up as will be understood by one of ordinaryskill in the art.

FIG. 75 is an isometric views of one example of a talar peg drill guide2180 in accordance with some embodiments. The talar peg drill guide 2180has an arcuate body configured to be placed on a joint space of theresected talus 265. In the embodiment illustrated in FIG. 75, talar pegdrill guide 2180 includes holes 2182, 2184, 2186 on its anterior side.One smaller hole 2182 is disposed between holes 2184, 2186 and isconfigured to receive a pin 2210. Holes 2184, 2186, which are disposedon either side of hole 2182, are configured to receive an anterior pegdrill 2212 (FIG. 79). In some embodiments, the superior surface of talarpeg drill guide 2180 has a contour that is similar to the contour of thearticulating surface of the ankle replacement prosthesis as shown inFIG. 75.

FIG. 76 illustrates one example of a talar implant holder 2188 inaccordance with some embodiments. As shown in FIG. 76, talar implantholder 76 can be a scissor-shaped tool having a first end 2190 and asecond end 2192, which are attached at an approximate center 2189. End2190 includes two arms 2194, 2196 with each arm 2194, 2196 defining arespective hole 2198, 2200 at its detached end. Holes 2198, 2200 aresized and configured to receive a surgeon's finger as a means to graspthe talar implant holder 2188. End 2192 defines two legs 2202, 2204 witheach leg 2202, 2204 being curved inwardly at its detached end 2206, 2208as a means to grasp a talar implant such as the talar peg drill guide2180.

Turning now to FIG. 77, the previously described tibial tray trial 210is inserted into the resected joint space between tibia 260 and talus265. The talar implant holder 2188 (FIG. 76) is used to insert the talarpeg drill guide 2180 into the joint space below tibial tray trial 210.The previously described poly trial insert 230 is inserted into thetibial trial 210. A trial reduction is performed to establish optimaltalar medial/lateral positioning. The foot F is slightly plantarflexedand a pin 2210 is inserted through the small hole 2182 in the center ofthe talar peg drill guide 2180 as a means to temporarily hold the talarpeg drill guide 2180 in position, as illustrated in FIG. 78.

FIG. 79 illustrates one example of an anterior peg drill 2212 inaccordance with some embodiments. Peg drill 2212 includes a stop 2214that is configured to limit the depth to which the peg drill 2212 isinserted into a bone. FIG. 80 illustrates anterior peg drill 2212 beinginserted into holes 2184, 2186 to drill holes 2216, 2218 shown in FIG.81. Holes 2216, 2218 formed by anterior peg drill 2212 being insertedinto holes 2284, 2286 are sized and configured to receive anterior pegs1202 for securing the talar dome 1200 to talus 265 (FIG. 99) asdescribed in greater detail below. FIG. 81 illustrates the holes 2216,2218 formed in talus 265 and the resected joint space once pins 2210 areremoved from in the tibia 260 and talus 265 as are the talar peg drillguide 2180, poly trial insert 230, and tibial trial 210.

FIGS. 82 and 83 illustrate one example of a tibial tray impaction insert2220 in accordance with some embodiments. As shown in FIGS. 82 and 83,the tibial tray impaction insert 2220 has a body 2222 having arectangular cuboid shape with curved insertion edge 2223 configured tobe received in tibial implant 1100 (FIGS. 84, 86) as described ingreater detail below. More particularly, body 2222 includes two opposedlonger sides 2234, 2236 that are separated from one another by curvedinsertion edge 2223 and end 2226 from which extension 2224 is disposed.Body 2222 also includes a superior side 2237 and an inferior side 2238.

The tibial tray impaction insert 2220 includes an extension 2224extending perpendicularly from end 2226 of tibial tray impaction insert2220. Extension 2224 also has a shape of a rectangular cuboid anddefines a hole 2228 on its anterior face 2230 that is sized andconfigured to receive an end 2266 of insertion handle 2264, which isshown in FIG. 87.

One example of a tibial implant 1100 is illustrated in FIGS. 84 and 85.Tibial implant 1100 has a rectangular cuboid body 1102 with a plurality(three in this example) pegs 1104 protruding out of the superior side1106 of body 1102. Pegs 1104 are configured to be received holes 263formed in the tibia 260 (FIG. 41) as described above. Holes 1108, 1110are defined by the anterior face 1112 of tibial implant 1100 with eachhole 1108, 1110 being sized and configured to receive two attachmentscrews 3500 (FIGS. 93A, 93B) for use with a poly inserter as describedin greater detail below. Tibial implant 1100 also includes opposedshoulders 1114, 1118 that are curved or chamfered relative to superiorside 1102 and sides 1120, 1122 of body 1102. A recessed area or recess2257 extends posteriorly from anterior face 1112 to insertion end (orposterior end) 1116 along the inferior side 1124 of implant 1100.

Recess 2257 is sized and configured to receive the sides 2234, 2236 andcurved edge 2223 of the tibial tray impaction insert 2220 as a means forholding the tibial tray impaction insert 2220 in place in the tibialimplant 1100 as shown in FIG. 86. The coupling between tibial trayimpaction insert 2220 and implant 1100 is achieved by sliding the tibialtray impaction insert 2220 into the tibial implant 1100. Bone cement(not shown) can be applied to the superior 1106, medial 1120, andlateral sides 1122 of the rectangular body 1102 of the tibial implant1100 while the anterior face 1112 of the tibial tray 1100 and inferiorside 2238 of the tibial implant impaction insert 2220 remains free ofany cement.

Turning now to FIG. 88, the assemblage of tibial tray implant 1100 andtibial tray impaction insert 2220 are shown being inserted into theresected joint space between tibia 260 and talus 265 using insertionhandle 2264, which is illustrated in FIG. 87. Insertion handle 2264 iscoupled to hole 2228 of tibial tray impaction insert 2220 and movesthree pegs 1104 of the tibial implant 1100 into alignment with holes 263formed in the tibia 260 (FIG. 41). The insertion handle 2264 is thenremoved from the hole 2228 of the rectangular extension 2224 of thetibial tray impaction insert 2220. A mallet or other impaction devicecan be used to strike extension 2230 of tibial impaction insert 2220 aswill be understood by one of ordinary skill in the art. The tibialimpaction insert 2220 can be slid out of engagement with tibial trayimplant 2220, which is configured to receive a poly implant/insert 1300using a poly insertion device 3100, 3300.

Poly Inserter and Related Components

FIGS. 89 through 95 illustrate the construction and operation of oneexample of a poly inserter 3100 and poly insert guide rail 3300 inaccordance with some embodiments. The purpose of poly inserter 3100 andpoly insert guide rail 3300 is to assist in the accurate placement of apoly implant 1300 as will be appreciated and understood after readingthe following description and referencing the figures.

FIG. 89 is an isometric view of a poly inserter 3100. Poly inserter 3100comprises an elongate body 3102 having gripping handle 3148 defining anaperture 3106 that is at least partially threaded and has an internaldiameter sized and configured to slidably receive a majority of a shaft3108 of a plunger rod 3110. Gripping handle 3148 defines a pair ofgripping holes 3152 and attachment screw receiving holes 3154.

A locking protrusion 3116 extends at an angle from the elongate body3102 adjacent to the proximal end 3104. Locking protrusion 3116 definesa rectangular opening 3114 that is sized and configured to receive alocking tab 3112 and a cylindrical opening 3118 that aligns withthreaded aperture 3106 for receiving plunger rod 3110 therethrough.Locking tab 3112 defines an aperture 3150 which is configured to receiveplunger rod 3110. A pair of opposed channels 3120 extend proximally fromthe distal end 3122 of the elongate body 310. Channels 3120 are sizedand configured to receive attachment screws 3500 (FIGS. 93A and 93B) andare. Opposed channels 3120 are aligned with attachment screw receivingholes 3154 in gripping handle 3148.

Plunger rod 3110 includes a handle 3124 at its proximal end 3126. Ashoulder 3132 is disposed adjacent to an enlarged threaded portion 3130that is disposed between the proximal end 3126 and a distal end 3128 ofplunger rod 3110. A push bar 3140 is connected to the distal end 3128 ofplunger rod 3110 by inserting a push bar extension 3144 into a blindhole 3142 located at the distal-most end of plunger rod 3110. In someembodiments, push bar 3140 is cross-pinned to plunger rod 3110 using apin 3138, which is inserted into hole 3134 located at distal end 3128.However, one of ordinary skill in the art will understand that othersecurement mechanisms can be used to couple push bar 3142 to plunger rod3110. A circumferential recess 3146 is defined about the externalsurface of the push bar extension 3144 and is sized and configured toreceive the pin 3138 therein for coupling the push bar 3140 to thedistal end 3128 of the plunger rod 3110. Distal end 3128 of plunger rod3100 further includes a distal notch 3127.

FIG. 90 is an isometric view of a poly inserter 3100 once assembled.Locking tab 3112 is inserted into rectangular opening 3114. Plunger rod3110 is inserted through threaded aperture 3106 and cylindrical opening3118. Push bar 3140 is then connected to the distal end 3128 of plungerrod 3110 as described above.

FIG. 91 is an isometric view of one example of a poly insert guide rail3300 in accordance with some embodiments. Although shown as a separatecomponent from poly inserter 3100, one of ordinary skill in the art willunderstand that guide rail 3300 can be integrally formed with polyinserter 3100. Guide rail 3300 includes a pair of spaced apart rails3302 connected to a central portion 3306 by a pair of downconnectors3304. Each rail 3302 has an interior edge 3308 and an exterior edge3310. In some embodiments, interior edges 3308 are rounded whileexterior edges 3310 are squared. Downconnectors 3304, which extend in adirection perpendicular to the direction in which rails extend andcentral portion 3306 extends, include a railing protrusion 3312 runningparallel with the length of rails 3302. Together, the interior edges3308 of rails 3302 and the railing protrusion 3312 define a pair ofrecesses 3314 configured to slide over the lateral edges 3156 of theelongate body 3102 of poly inserter 3100. Poly insert guide rail 3300 iscoupled to poly inserter 3100 by sliding poly inserter guide rail 3300over poly inserter 3100 such that recesses 3314 are aligned with lateraledges 3156 of elongate body 3102.

FIG. 92 is an isometric view of a poly inserter 3100 coupled with a polyinserter guide rail 3300 for guiding a poly insert 1300, which is showndisposed between rails 3302. In use, plunger rod 3110 is pulledproximally and locked in its proximal-most position by engaging lockingtab 3112. For example, with plunger rod 3110 pulled to its proximal-mostposition, distal notch 3127 is aligned with locking tab 3112. Lockingtab 3112 is depressed into rectangular opening 3114, causing thenarrower top portion of aperture 3150 to engage distal notch 3127 andhold plunger rod 3110 in the proximal-most position. This engagementprevents plunger rod 3110 from prematurely implanting poly implant 1300.Plunger rod 3110 is prevented from being fully removed as push bar 3140has a length that is larger than cylindrical opening 3118. With theplunger rod 3110 locked relative to the position of the poly inserter3100, a poly implant 1300 is positioned between extending rails 3302 ofpoly inserter guide rail 3300 as shown in FIG. 92.

FIG. 93A is an isometric view of attachment screws 3500 installed intibial implant 1100. Attachment screws 3500 comprise a threaded proximalend 3504, a shoulder portion 3508, a shaft 3502, and a threaded distalportion 3506, which is shown in FIG. 93B. Attachment screws 3500 areconfigured to be threadably inserted into tibial implant 1100 usingthreaded distal end 3506. Attachment screws 3500 are additionallyconfigured, once threadably inserted into tibial implant 1100, to beinserted into opposed channels 3120 of poly inserter 3100.

FIG. 93B is an isometric view of attachment screws 3500 as they arebeing installed in tibial implant 1100. In some embodiments, asillustrated in FIG. 93B, attachment screw 3500 has a non-threaded tip3510 disposed adjacent to threaded distal portion 3506, which engagesthreaded holes 1108, 1110 of tibial implant 1100.

FIG. 94 is an isometric view of a poly inserter 3100 connected toattachment screws 3500 installed in the tibial tray 1100 with the polyinsert removed for simplifying the view. With attachment screws 3500threadably inserted into threaded holes 1108, 1110 of tibial implant1100, the assembled poly inserter 3100 is lowered onto attachment screws3500 such that attachment screws 3500 are disposed within opposedchannels 3120. An attachment nut 3602 is threadably connected to thethreaded proximal end 3504 of each attachment screw 3500 to secure polyinserter to the anterior face 1112 of the tibial implant 1100.

FIGS. 95A and 95B are lateral side views of the operation of polyinserter 3100 once secured to tibial implant 1100 in accordance withsome embodiments. Locking tab 3112 (not shown in FIGS. 95A and 95B) ispulled in a direction away from elongate body 3102 such that the widerdiameter base of aperture 3150 is aligned with plunger rod 3110 topermit plunger rod 3110 to slide relative to the elongate body 3102 ofpoly inserter 3100. Handle 3124 is used to slide the plunger rod 3110distally such that poly implant 1300, positioned between rails 3302 ofpoly inserter guide rail 3300, is slid distally into the resected tibialbone space.

Plunger rod 3110 is moved distally until enlarged threaded portion 3130abuts threaded hole 3106 of poly inserter 3100 at which point plungerrod 3110 is rotated about its longitudinal axis to facilitate distal(axial) translation of the plunger rod 3110 relative to elongate body3102. Poly implant 1300 does not rotate as the plunger rod 3110 rotatessince the plunger rod 3110 is allowed to spin relative to the push bar3140 that is in abutting contact with the poly implant 1300 due to thepin 3138 that is received within the circumferential slot 3146 definedby push bar extension 3144. Shoulder 3132 prevents excessive downwardmotion of poly implant 1300 because its diameter is larger than threadedaperture 3106, arresting movement once the entire enlarged threadedportion 3130 has been threadably inserted into threaded aperture 3106.

When poly implant 1300 has been inserted into resected tibial bonespace, poly inserter 3100 is removed from its engagement with polyimplant 1300 by removing attachment nuts 3602 and pulling on handle3124. Due to the threaded engagement between enlarged threaded portion3130 and threaded aperture 3106, poly inserter 3100 is slid along theattachment screws 3500 until disengaged. As an alternative, polyinserter 3100 may be removed by pulling on gripping handle 3148.Attachment screws 3500 are then unscrewed from tibial implant 1100.

Ankle Replacement Prosthesis

FIGS. 96-98 provide various views of the complete ankle replacementprosthesis 1000 in accordance with some embodiments, and FIG. 99illustrates the position of the ankle replacement prosthesis 1000 uponcompletion of an ankle replacement procedure.

Ankle replacement prosthesis 1000 comprises tibial implant 1100, talarimplant 1200, and poly implant 1300.

Upon completion of an ankle replacement procedure, tibial implant 1100is connected to the tibia 260, with pegs 1104 disposed within peg holes263 in the resectioned tibia 260. Talar implant 1200 is connected to thetalus 265, with talar dome anterior pegs 1202 disposed within holes 2214and 2216. Poly implant 1300 is inserted and disposed between tibialimplant 1100 and talar implant 1200.

Method of Ankle Replacement

A method of performing an ankle replacement is disclosed using theabove-described system.

An anterior incision is made lateral of the tibialis avoiding theanterior tendons and never bundle to expose the tibia 260, talus 265,and a portion of the midfoot. In some embodiments, the incision isapproximately 125 mm long; however, one of ordinary skill in the artwill understand that the incision can be greater or less than 125 mm.Gutter fork 10, illustrated in FIG. 1, is inserted into the medialgutter of the ankle joint.

Once medial gutter fork 10 is inserted into the medial gutter of theankle joint, rotation guide slide 20 is operationally connected tomedial gutter fork 10 by placing guide hole 18 over shaft 2 asillustrated in FIG. 4A. Rotation guide slide 20 is positioned witheither first channel 16 or second channel 17 facing away from the tibia260. Rotation guide pointer 30 is operationally connected to rotationguide slide 20 by sliding protrusion 26 into either first channel 16 orsecond channel 17, whichever is facing away from the tibia 260. Thusassembled, an operator uses finger tab 27 to rotate the combinedrotation guide slide 20 and rotation guide pointer 30 about an axisdefined by shaft 2. An operator may also use finger tab 27 to sliderotation guide pointer 30 along an axis defined by first channel 16 orsecond channel 17. The operator thus uses finger tab 27 to rotate thecombined rotation guide slide 20 and rotation guide pointer 30 and sliderotation guide pointer 30 until pointer extension 24 is approximatelyaligned with the mechanical axis of the tibia 260.

Once the rotation guide assembly 40 is positioned as described above,the position of the rotation guide pointer 30 relative to the rotationguide slide 20 is fixed by tightening screws 37. A first guide pin 50 isinserted through pin hole 28 and into the tibia 260 as shown in FIG. 4B.With first guide pin 50 thus inserted, the entire rotation guideassembly 40 is removed, leaving first guide pin 50 in place asillustrated in FIG. 5.

With attention now to FIG. 12, the alignment frame assembly 140 isassembled by inserting the distal end 104 of the proximal alignmentframe 109 into the distal alignment frame 105. The alignment frameassembly 140 is connected to the tibia 260 by sliding the hole 194 ofthe distal end 124 of the distal alignment frame 105 over the firstguide pin 50. A pin 154 is installed percutaneously through the hole 103at the proximal end 102 of the proximal alignment frame 109 into atibial tuberosity.

Alternatively, the knee bracket 142 and rubber strap 148 can be used tosecure the alignment frame assembly 140 to the proximal end of the tibia260, as illustrated in FIGS. 13A and 13B. The knee bracket post 146 isinserted into the hole 103 at the proximal end 102 of the proximalalignment frame 109. The knee bracket base 144 is then positioned overthe proximal end of the tibia 260 and secured in place using the rubberstrap 148 by wrapping the rubber strap 148 laterally around the tibia260 and attaching the hooks 152 of the knee bracket base 144 to theholes 151 of the rubber strap 148.

Turning now to FIG. 14, once the alignment frame assembly 140 isconnected to the proximal end of the tibia 260, the distal end 124 ofthe distal alignment frame 105 is placed above the tibia 260 such that agap, G, is provided between the distal alignment frame 105 and the tibia260. In some embodiments, the gap G is approximately 20-25 mm from theframe 105 to the tibia 260; however, gap G can have other dimensionsthat are greater than or less than 20-25 mm. Once the desired gap isachieved, distal knob 196 is turned to loosely lock the distal end 124of the distal alignment frame 105 to the first guide pin 50.

As illustrated in FIGS. 13A-16, the proximal alignment frame 109 isadjustable in length and is maintained at a fixed length by turning themost proximal knob 128 of the distal alignment frame 105. The secondknob 108 of the proximal alignment frame 109 is then turned as indicatedby arrow A1 to loosely lock the alignment frame assembly 140 to the pin154 and/or knee bracket post 146.

The angel wing alignment guide 160 is then attached to the alignmentframe assembly 140 by inserting the angel wing alignment guide post 166into the slot 138 at the distal end 124 of the distal alignment frame105, as illustrated in FIG. 17. A set screw (not shown) is then insertedthrough hole 139 that intersects the slot 138 and secured with a hexdriver 174. The set screw (not shown) can be loosened to allowproximal/distal adjustment of the angel wing alignment guide 160.

As shown in FIG. 18, coronal rotation adjustments can be made to theproximal alignment frame 109. The first knob 106 at the proximal end 102of the proximal alignment frame 109 can be turned as indicated by arrowA2 to allow adjustment of the angle of a perpendicular slot 101 at theproximal end 102 of the proximal alignment frame 109 for coronalrotation adjustment as indicated by arrows A3 and A4. The position ofthe angel wing alignment guide 160 can be viewed under A/P fluoroscopyto establish coronal alignment, which is typically parallel to thenatural joint line, as illustrated in FIG. 20. Once coronal alignment isestablished, first knob 106 is turned in direction A2 to lock therelative positions of proximal alignment frame 109 and angel wingalignment guide 160.

Continuing now to FIG. 21, the alignment rod 170 is inserted through oneof the holes 164 in either side of the angel wing alignment guide base162 where it slides along the hole 164 until it reaches the stop collar172. Either the second knob 108 or the distal knob 196 of the alignmentframe assembly 140 can be turned to allow sagittal rotation adjustment,as illustrated in FIG. 22. The position of the alignment rod 170 can beviewed under lateral fluoroscopy to establish sagittal rotation, whichis typically parallel to a shaft of the tibia 260, as illustrated inFIG. 23.

The angel wing alignment guide 160 and alignment rod 170 are removedonce the desired position has been achieved. As illustrated in FIGS. 24and 25, two pin sleeves 176 are inserted into two aligned holes 132 ofthe plurality of holes 132 at the distal end 124 of the distal alignmentframe 105 that provide the optimal bone purchase, which is typically thetwo center holes 132. A trocar 178, as illustrated in FIG. 24B, isinserted into each of the pin sleeves 176 to create “stab wounds” forpercutaneous pins, as illustrated in FIG. 26. The trocar 178 is thenremoved.

As illustrated in FIG. 27, a pin 150 is inserted into each of the pinsleeves 176 and through both cortices of the tibia 260. Once the pins150 are placed, the pin sleeves 176 are removed and the second knob 108and distal knob 196 are loosened to remove the alignment frame assembly140. The proximal tibial pin 154 or knee bracket 142 and the first guidepin 50 are then removed, leaving pins 150 in the tibia 260, asillustrated in FIG. 28.

The adjustment block 100 of FIG. 29 is lowered onto pins 150 until firstframe 110 is slightly above the anterior surface of the tibia 260.Locking screw 112 is then rotated to lock the position of adjustmentblock 100 relative to the tibia 260.

With attention now to FIG. 35, a drill guide 280 is connected to theadjustment block 100, lowered onto the anterior surface of the tibia260, and locked into position using a set screw (not shown). Drill guide280 is then translated to the center of the ankle joint usingproximal-distal adjustment knob 111 and the medial-lateral adjustmentknobs 121 a and 121 b. Once centered, the position of drill guide 280 islocked using set screws (not shown).

The operator sizes the tibial implant 1100 of the ankle replacementsystem by mounting a drill guide 280 on the tool holder and adjustingits position using knobs 111, 121, 131. The physician views an X-ray ofthe tibia bone 260 and drill guide 280 and determines whether it is theoptimum size and position for the patient. The position can be adjustedbased on the X-ray, using knobs 111, 121, 131. If the size of theresectioning cut corresponding to the drill guide 280 is too large ortoo small, the physician removes the drill guide, selects a differentsize drill guide, and snaps the new drill guide onto the tool holder 134of the adjustment block 100. The drill guide is then repositionedagainst the tibia 260, imaged by fluoroscope, and the size is againchecked.

With attention now to FIGS. 50-53, the sagittal sizing guide assembly400 is then used to fluoroscopically identify the appropriate talarimplant 1200 size and to set the appropriate height of talar resection.Sagittal sizing guide assembly 400 is connected to coronal sizing anddrill guide 380 by lowering guide arm 402 such that mating extension 412is engaged with slot 390. For minimal parallax distortion the sagittalsizing guide assembly 400 should be oriented to hang on the side of theankle closest to the c-arm receiver and the sagittal sizing guideassembly 400 should be placed as close to the bones of the ankle joint,particularly the tibia 260, as possible. The sagittal guides are used toappropriately evaluate and position the proximal/distal resectionplacement of tibial and talar resections. In some embodiments, the talarsize and talar chamfer preparations are estimated with the talar profile486 on the distal side of sagittal guide. The tibia tray length is alsoindicated with the tibial pin length which is the proximal pin 480. Thepush button 476 allows for appropriate AP placement.

As described above, the sagittal sizing guide body 460 includes acombination of dowel 482 and fluoro-opaque profile 486 to advantageouslyenable the sizing of a talar implant 1200 and the appropriate height ofthe talar resection to be checked using fluoroscopy prior to resectingthe talus. The height of resection height can be adjusted and locked inby adjusting knob 111 of adjustment block 100. A number of sagittalsizing guide bodies 460 can be available such that a surgeon or otherhealth care professional can select the appropriate size based on theactual anatomy of the patient. The differently sized sagittal sizingguide bodies 460 can be swapped for one another until the appropriatesagittal sizing guide body 460 is identified.

As illustrated in FIG. 36, to resect the tibia 260, drill guide 280 isfirst pinned to the tibia 260 using fixation pins 287 inserted throughthe pin holes 282 and trimmed such that pins 287 extend slightly abovethe drill guide 280. Then the operator drills holes in the tibia 260through the guides holes 281 using the drill guide 280 and drill 288.The holes thus drilled in the bone 260 define proximal corners of aresectioning cut to be performed in the tibia. The operator then removesthe drill guide 280, while leaving the pins 287 in place (in the distalportion of the tibia 260 to be removed by the resectioning). Whileremoving the drill guide 280, the adjustment block 100 can remain lockedin the first coordinates with the first frame 110 adjusted to the sameproximal-distal coordinate and the second frame 120 adjusted to the samemedial-lateral coordinate.

With attention now to FIG. 37, a cut guide 290 corresponding topreviously-utilized drill guide 280 is connected to adjustment block 100and fixation pins 287. In some embodiments, additional fixation pins 297are used to pin cut guide 290 to the talus bone 265. Once the cut guide290 is positioned and pinned, the operator performs the resectioningcuts through the guide slots 295, cutting the bone to connect thepreviously drilled holes. In some embodiments, such as the embodimentillustrated in FIG. 37, one cut guide 290 is used for both the tibiaresection and the first cut of the talar resection. The cut guide 290 isthen removed from the surgery site, and detached from the adjustmentblock 100. The sections of the tibia 260 and talus 265 that have beencut are removed, along with the fixation pins 287 and 297. Various toolssuch as a corner chisel, bone removal screw, posterior capsule releasetool, and bone rasp may be used to complete the resection, remove theresected portions from the surgery site, and clean the resection edges.

In some embodiments, a single coronal sizing and drill guide 380 is usedin place of a drill guide 280 and cut guide 290.

As illustrated in FIG. 38, following the initial resectioning theoperator inserts the tibia trial 210 into the resected joint space andseated flush against the resected tibia 260. In some embodiments, theoperator leaves adjustment block 100 locked to fixation pins 150 andsnaps the tibia trial 210 onto the tool holder 134. In otherembodiments, the adjustment block 100 is removed and tibia trial 210 ispinned in place using fixation pins.

With tibia trial 210 in place and seated flush against the resectedtibia 260, the operator drills a plurality (e.g., 3) peg holes 263 inthe distal surface 262 of the resectioned tibia 260 using the tibia pegdrill 299. In some embodiments, a tibial peg punch is used to preparepeg holes 263. The holes 212 (FIG. 31) of the tibia trial 210 are usedto locate peg holes 263. FIG. 41 shows the distal end 261 of the tibia260 at the completion of the peg drilling, with the three peg holes 263in the resectioned surface 262 of the tibia.

With attention now to FIGS. 42-45, the operator now performs a trialreduction to ensure the correct height of the poly trial insert 230 andthe correct position of the talus dome. Floating trial 250 and polytrial insert 230 are inserted into the resected joint space. The talarimplant anterior-posterior coordinate is determined by moving thefloating trial 250 to the location where it best articulates with theconcave surface 232 of the poly trial insert 230. Once the position offloating trial 250 is optimized, two additional fixation pins 298 areinserted through the pin holes 253 of the floating trial 250. Floatingtrial 250 and poly insert trial 230 are then removed from theresectioned joint space and two additional resectioning cuts, describedbelow, are performed to match the geometry of the talar dome to thetalar implant 1200 of the ankle replacement system.

As shown in FIG. 60, the talar resection guide base 2100 is connected tothe talus 265 by sliding holes 2104, 2106 of the talar resection guidebase 2100 over fixation pins 298. Temporary fixation screws or pins2154, 2156 are inserted into the two holes 2108, 2110 on either side ofthe base 2100 using a T-handle pin driver 2158. A bone saw 2160 isinserted through the lateral slit 2128 in the shoulder 2124 of the slot2102 of the talar resection guide base 2100. The saw blade or bone saw2160 is used to resect the talus 265 to create the posterior talarchamfer 2170, as illustrated in FIG. 74. Once the area is resected, thebone saw 2160 is and resected bone piece are removed from the surgerysite.

As illustrated in FIG. 65, the anterior talar pilot guide 2130 is theninserted into the talar resection guide base 2100 and a talar reamer2162 is used to make plunge cuts through the interconnecting holes 2132of the anterior talar pilot guide 2130. As illustrated in FIG. 68, theanterior talar pilot guide 2130 is removed from the talar resectionguide base 2100 and is rotated 180°. The talar reamer 2162 is then usedto plunge cut through the interconnecting holes 2132 of the anteriortalar pilot guide 2130 to prepare the talar surface for an anterior flat2174 as best seen in FIG. 74. The anterior talar pilot guide 2130 isthen removed from the talar resection guide base 2100.

Next, as shown in FIG. 70, an anterior talar finish guide 2142 isinserted into the talar resection guide base 2100 and the talar reamer2162 is used to perform the finishing cuts for the anterior chamfer 2172by sliding the talar reamer 2162 from side to side within the slot 2144of the finish guide 2142, as indicated by arrow AR1. The anterior talarfinish guide 2142 is then removed from the talar resection guide base2100, is rotated 180°, and re-engaged with the talar resection guidebase 2100. The talar reamer 2162 is then used to perform the finishingcuts for the anterior talar flat 2174 by sliding the talar reamer 2162from side to side within the slot of the finish guide 2142, as indicatedby arrow AR2. Having completed the talar finishing cuts, the anteriortalar finish guide 2142, talar resection guide base 2100 and temporaryfixation pins 2154, 2156 are removed from the surgery site.

Having completed resectioning the ankle joint, the tibial trial 210 isagain positioned in the resectioned tibial bone space and connected toadjustment block 100. In alternative embodiments, the tibial trial 210is again pinned in place using fixation pins. The talar implant holder2188 is used to insert the talar peg drill guide 2180 into the jointspace of the resected talus 265. The poly trial insert 230 is insertedinto the tibial trial 210. A trial reduction is performed to establishoptimal talar medial/lateral positioning. The foot F is slightlyplantarflexed and a pin 2210 is inserted through the small hole 2182 inthe center of the talar peg drill guide 2180 as a means to temporarilyhold the talar peg drill guide 2180 in position, as illustrated in FIG.78.

As illustrated in FIG. 80, anterior peg drill 2212 is inserted into eachof the holes 2184, 2186 of the talar peg drill guide 2180 and is used todrill holes 2214, 2216 for the talar dome anterior pegs 1202. Pin 2210in the talus 265 is removed and the talar peg drill guide 2180, polytrial insert 230, and tibial trial 210 are also removed from the surgerysite.

With attention now to FIGS. 83-86, the tibial tray impaction insert 2220is attached to the tibial implant 1100 in preparation for insertion oftibial implant 1100. Bone cement (not shown) may be applied to thesuperior, medial and lateral sides 1106, 1120, 1122 of the rectangularbody 1102 of the tibial implant 1100, but the anterior face 1112 andinferior side 2238 of the tibial implant impaction insert 2220 remainfree of bone cement. The insertion handle 2264 is inserted into the hole2228 of the rectangular extension 2224 of the tibial tray impactioninsert 2220. The insertion handle 2264 is used to insert the tibialimplant 1100 and tibial tray impaction insert 2220 into the resectedspace of the tibia 260. Tibial implant 1100 is inserted and connected totibia 260 with the three pegs 1104 of the tibial implant 1100 insertedinto peg holes 263. The insertion handle 2264 is then removed, and anoffset tibial implant impactor may be used to complete seating of thetibial implant 1100. Fluoroscopic imaging may be used to verify thetibial implant 1100 is fully seated.

The talar implant 1200 is then prepared for implantation. In someembodiments, bone cement is applied to portions of the talar implant1200 which will seat on the talus 265. Talar implant 1200 is thenconnected to the talus 265, with talar dome anterior pegs 1202 disposedwithin holes 2214 and 2216. A talar implant impactor may be used tocomplete seating of the talar implant 1200, and fluoroscopic imaging maybe used to verify the talar implant 1200 is fully seated.

The ankle joint is now prepared for a poly implant 1300. Poly inserter3100 is assembled as shown in FIG. 90 by inserting locking tab 3112 intorectangular opening 3114, inserting plunger rod 3110 through threadedaperture 3106 and cylindrical opening 3118, and connecting push bar 3140to the distal end 3128 of plunger rod 3110 as described above. Polyinsert guide rail 3300 is then coupled to poly inserter 3100.

With attention now to FIGS. 93A and 93B, attachment screws 3500 arethreadably inserted into tibial implant 1100. Poly inserter 3100 islowered onto attachment screws 3500 such that attachment screws 3500 aredisposed within opposed channels 3120. An attachment nut 3602 isthreadably connected to the threaded proximal end 3504 of eachattachment screw 3500 to secure poly inserter to the anterior face 1112of the tibial implant 1100.

As illustrated in FIGS. 95A and 95B, locking tab 3112 is pulled in adirection perpendicular to elongate body 3102 such that the widerdiameter base of aperture 3150 is aligned with plunger rod 3110 topermit plunger rod 3110 to slide relative to the elongate body 3102 ofpoly inserter 3100. Handle 3124 is used to slide the plunger rod 3110distally such that poly implant 1300, positioned between extending rails3302 of poly inserter guide rail 3300, is slid distally into theresected tibial bone space.

Once poly implant 1300 has been inserted into resected tibial bonespace, poly inserter 3100 is removed from its engagement with polyimplant 1300 by removing attachment nuts 3602 and pulling on handle3124. Attachment screws 3500 are then unscrewed from tibial implant1100.

With attention now to FIG. 99, upon completion of an ankle replacementprocedure, tibial implant 1100 is connected to the tibia 260, with pegs1104 disposed within peg holes 263 in the resectioned tibia 260. Talarimplant 1200 is connected to the talus 265, with talar dome anteriorpegs 1202 disposed within holes 2214 and 2216. Poly implant 1300 isinserted and disposed between tibial implant 1100 and talar implant1200.

Patient-Specific Adapter

As noted above, various modifications can be made to the disclosedsystems and methods. One example of such a modification is to utilizepatient-specific locator mounts, such as those described in commonlyassigned U.S. patent application Ser. No. 12/711,307, entitled “Methodfor Forming a Patient Specific Surgical Guide Mount, U.S. patentapplication Ser. No. 13/330,091, entitled “Orthopedic Surgical Guide,”and U.S. patent application Ser. No. 13/464,175, entitled “OrthopedicSurgical Guide,” the entireties of which are incorporated by referenceherein, to mount the coronal sizing and drill guide 380 to a tibia 260instead of using the adjustment block 300 and other associatedinstrumentation.

For example and referring to FIG. 100, a patient-specific mount 3000 canbe fabricated to be positioned at the distal end of tibia 260. Thepatient-specific mount 3000 includes a pin holder extension 3002 that isconfigured to hold a pin 3004 in a position such that pin 2004 extendsparallel to the mechanical (e.g., longitudinal) axis of the tibia 260.Pin 3004 can be used to check the proper alignment using fluoroscopy aswill be understood by one of ordinary skill in the art. When thepatient-specific guide is properly positioned, pins 287, such as thosedescribed above to secure cut guide 290 (FIGS. 36 and 37), are insertedthrough holes 3006 that are positioned to align with holes 282 of drillguide 280 or corresponding holes of cut guide 290 and/or coronal sizingand drill guide 380. Patient-specific mount 3000 also includes holes3008 that are sized and configured to receive pins 3010. Once pins 287and 3010 have been installed, patient-specific guide mount 3000 is slidover these pins 287, 3010 and removed.

As shown in FIG. 101, coronal sizing and drill guide 380 can be slidover pins 287 and a conversion instrument 3500 is slid over pins 3010.As best seen in FIGS. 102-105, conversion instrument 3500 includes anelongate body 3502 extending from a proximal end 3504 to a distal end3506. Conversion instrument 3500 includes a first and second oblongsections 3508, 3510 that extend transversely with respect to thelongitudinal direction of instrument 3500. Each oblong section 3508,3510 defines a respective plurality of interconnected holes 3512, 3514.

The distal end 3506 of instrument 3500 includes a dovetail joint 3516having a similar construction to the dovetail joint 332 described abovewith respect to tool holder 330. A cavity 3518 is defined at the distalend 3506 of instrument 3500 between rails 3520. Cavity 3518 is sized andconfigured to receive a locking wedge 3522 as best seen in FIGS. 104 and105. A through hole 3524 extends from a first side 3526 to a second side3528 of the distal end 3506 of instrument 3500 and is sized andconfigured to receive a locking bolt 3530 therein. Locking bolt 3530includes a pair of spaced apart shoulders 3532, 3534 along its length.Shoulders 3532, 3534 are configured to abut angled surfaces 3536, 3538of locking wedge 3522 to press locking wedge 3522 against a dovetailmember of drill guide 280, cut guide 290, and/or coronal sizing anddrill guide 380. In some embodiments, locking bolt 3530 is cross-pinnedwithin hole 3524 by a pin 3540 as best seen in FIG. 105.

Locking wedge 3522 is biased in a proximal direction by compressionsprings 3542, 3544, which are cross-pinned by pins 3546, 3548 such thatthey are disposed within channels 3550, 3552 defined by locking wedge3522. Locking wedge 3522 also defines a vertical slot 3554 that is sizedand configured to receive pin 3556 to cross pin wedge 3522 within cavity3518. Turning back to FIG. 102, holes 3558 are defined by the distal end3506 of instrument 3500 on either side of dovetail joint 3516. Holes3558 are sized and configured to receive pins 3010 therein as shown inFIG. 101.

The conversion instrument 3500 can be secured to coronal sizing anddrill guide 380 by having dovetail extension 394 of coronal sizing anddrill guide 380 be received within dovetail joint 3516. A hex driver,such as hex driver 174 illustrated in FIG. 19, is used to tightenlocking bolt 3530 within hole 3524. The rotation of locking bolt 3530causes the engagement end 3560 (FIG. 105) of locking bolt, which can bethreaded or have another engagement feature disposed thereon, engage acorresponding structure disposed within distal end of instrument 3500and axially move such that shoulders 3532, 3534 of bolt 3530 contactangled surfaces 3536, 3538 of locking wedge 3522. The axial movement ofbolt 3522 causes locking wedge 3522 to move distally compressingcompression springs 3548, 3550 and forcing the bottom surface of lockingwedge 3522 against dovetail extension, which is frictionally locked byrails 3520. The remainder of the surgical procedure can be carried outas described above.

In some embodiments, a surgical alignment system includes a guide arm, aratchet arm frame configured to be coupled slidably to the guide arm, aratchet arm configured to be coupled to the ratchet arm frame, and asagittal sizing guide body configured to be coupled to the ratchet arm.The sagittal sizing guide body includes a first radiopaque objectdisposed at a first position and a second radiopaque object disposed ata second position that is spaced apart from the first position.

In some embodiments, the first radiopaque object includes a pin disposedin a first hole defined by the sagittal sizing guide body, and thesecond radiopaque object has a profile that corresponds to a profile ofa first prosthesis component.

In some embodiments, the pin has a length that corresponds to a lengthof a second prosthesis component.

In some embodiments, the first prosthesis component is a talar componentof an ankle replacement system, and the second prosthesis component is atibial component of the ankle replacement system.

In some embodiments, the guide arm is configured to be coupled to acoronal sizing and drill guide.

In some embodiments, the ratchet arm frame defines an opening sized andconfigured to receive the guide arm slidably therein.

In some embodiments, the sagittal sizing guide body defines a channelsized and configured to receive the ratchet arm therein.

In some embodiments, the sagittal sizing guide body is configured toreceive a biasing member and a push button for locking the sizing guidebody relative to the ratchet arm.

In some embodiments, the guide arm extends from the ratchet arm frame ina first direction that is different from a second direction in which theratchet arm extends from the ratchet arm frame.

In some embodiments, a method includes coupling a guide arm to a firstfixture coupled to a first bone and inserting an end of the guide arminto an opening defined by a ratchet arm frame. The ratchet arm frame iscoupled to a ratchet arm that extends in a first longitudinal directionthat is different from a direction in which the guide arm extends alongits length. The ratchet arm is inserted into a channel defined by asagittal sizing guide body to couple the sagittal sizing guide body tothe ratchet arm. The sagittal sizing guide body includes a firstradiopaque object disposed at a first position and a second radiopaqueobject disposed at a second position that is spaced apart from the firstposition.

In some embodiments, the first radiopaque object includes a pin disposedin a first hole defined by the sagittal sizing guide body. The pin has alength that corresponds to a first prosthesis component. The secondradiopaque object has a profile that corresponds to a profile of asecond prosthesis component.

In some embodiments, a method includes using fluoroscopy to check a sizeof the first and second radiopaque elements of the sagittal sizing guidebody relative to the first bone and a second bone.

In some embodiments, the sagittal sizing guide body is a first sagittalsizing guide body. A method includes uncoupling the first sagittalsizing guide body from the ratchet arm, and inserting the ratchet arminto a channel defined by a second sagittal sizing guide body to couplethe second sagittal sizing guide body to the ratchet arm. The secondsagittal sizing guide body includes third and fourth radiopaque objectsthat respectively correspond to a differently sized first prosthesiscomponent and a differently sized second prosthesis component.Fluoroscopy is used to check a size of the third and fourth radiopaqueelements relative to the first bone and the second bone.

In some embodiments, coupling the guide arm to the first fixtureincludes inserting a mating extension disposed at a second end of theguide arm into a slot defined by a coronal sizing and drill guide thatis coupled to an adjustment block.

In some embodiments, the coronal sizing and drill guide includes a thirdradiopaque object having a size and shape of the first prosthesiscomponent viewed in an anterior-posterior direction.

In some embodiments, a method includes inserting a dovetail extension ofa coronal sizing and drill guide into a cavity of a dovetail joint of anadjustment block that is coupled to a tibia, securing the dovetailextension within the cavity, and using fluoroscopy to check a size of aradiopaque element of the coronal sizing and drill guide relative to atleast the tibia. The radiopaque element has a size and shape thatcorresponds to a profile of a prosthesis component of a first typehaving a first size when viewed in an anterior-posterior direction.

In some embodiments, the coronal sizing and drill guide is a firstcoronal sizing and drill guide. A method includes uncoupling the firstcoronal sizing and drill guide from the adjustment block, inserting adovetail extension of a second coronal sizing and drill guide into thecavity of the dovetail joint of the adjustment block, securing thedovetail extension of the second coronal sizing and drill guide withinthe cavity, and using fluoroscopy to check a size of a radiopaqueelement of the second coronal sizing and drill guide relative to atleast the tibia. The radiopaque element has a size and shape thatcorresponds to a profile of the prosthesis component of the first typehaving a second size when viewed in the anterior-posterior direction.

In some embodiments, a method includes inserting pins into holes definedby the coronal sizing and drill guide to secure the coronal sizing andrill guide to at least the tibia and drilling holes in the tibia byinserting a drill into a first drill hole and a second drill holedefined by the coronal sizing and drill guide. The first and seconddrill holes are positioned such that they intersect the radiopaqueelement at two different locations.

In some embodiments, a method includes inserting a mating extension of aguide arm into a slot defined by the coronal sizing and drill guide tocouple the guide arm to the coronal sizing and drill guide, andinserting an end of the guide arm into an opening defined by a ratchetarm frame. The ratchet arm frame is coupled to a ratchet arm thatextends in a first longitudinal direction that is different from adirection in which the guide arm extends along its length. The ratchetarm is inserted into a channel defined by a sagittal sizing guide bodyto couple the sagittal sizing guide body to the ratchet arm. Thesagittal sizing guide body includes a first radiopaque object disposedat a first position and a second radiopaque object disposed at a secondposition that is spaced apart from the first position.

In some embodiments, the first radiopaque object includes a pin disposedin a first hole defined by the sagittal sizing guide body, the pinhaving a length that corresponds to a length of the prosthesis componentof the first type, and the second radiopaque object has a profile thatcorresponds to a profile of a prosthesis component of a second type.

In some embodiments, a surgical positioning system includes a firstcomponent including an elongate shaft coupled to a head. The head isconfigured to be disposed in a joint between a first bone and a secondbone. A second component includes diverging first and second portions.The first portion defines a hole that is sized and configured to receivethe shaft of the first component. The second portion defines a firstchannel on a first side. A third component is configured to be coupledto the second component. The third component includes a base and apointer extension. The base includes a protrusion that is sized andconfigured to be received slidably within the first slot.

In some embodiments, the first channel is defined by a bottom wall and apair of spaced apart side walls that extend from the bottom wall.

In some embodiments, the side walls extend from the bottom wall at anon-orthogonal angle.

In some embodiments, the second component defines a second channel on asecond side, and the protrusion of the third component is configured tobe received slidably within the second channel.

In some embodiments, the second channel is defined by a bottom wall anda pair of spaced apart side walls that extend from the bottom wall.

In some embodiments, the pointer extension defines a hole along itslength that is sized and configured to receive a pin therein.

In some embodiments, the head includes a first prong and a second prongthat are sized and configured to be received within a medial gutter ofan ankle joint.

In some embodiments, the hole defined by the first portion is configuredto receive the shaft of the first component rotatably therein.

In some embodiments, a method includes inserting a head of a firstcomponent of a surgical positioning system into a joint between a firstbone and a second bone and sliding a second component of the surgicalpositioning system onto a shaft of the first component. The secondcomponent includes diverging first and second portions. The firstportion defines a hole that is sized and configured to receive the shaftof the first component, and the second portion defines a first channelon a first side. A third component of the surgical positioning system isslid into engagement with the second component by inserting a protrusionof the third component into the first channel defined by the secondcomponent.

In some embodiments, a method includes rotating the second componentrelative to the first component and sliding the third component relativeto the second component to align a pointer extension of the thirdcomponent with an axis of the first bone.

In some embodiments, a method includes checking the alignment betweenthe pointer extension and the axis of the bone using fluoroscopy.

In some embodiments, a method includes inserting a pin into a holedefined along a length of the pointer extension.

In some embodiments, a method includes removing the surgical positioningsystem from its engagement with the first and second bones while leavingthe pin positioned within the first bone and coupling an alignmentsystem to the pin.

In some embodiments, the first bone is a tibia, the second bone is atalus, and the joint is an ankle.

In some embodiments, a cutting system includes a cutting base having abody defining a slot, a first set of holes, and a second set of holes.The first set of holes being positioned along a first flange extendingaway from the slot in a first direction, and the second set of holesbeing positioned along a second flange extending from the slot in asecond direction that is opposite the first direction. A first cuttingguide has a body defining a plurality of holes that overlap one anotherto form a slot having a width that is smaller than a width of the slotdefined by the cutting base. The first cutting guide includes a set ofpegs that extend inferiorly from the first cutting guide and are sizedand configured to be received with the first set of holes or the secondset of holes to secure the first cutting guide to the cutting base.

In some embodiments, the cutting base defines a third set of holespositioned along the first flange and a fourth set of holes positionedalong the second flange. The third and fourth sets of holes areconfigured to receive pins for securing the cutting base to a bonesurface.

In some embodiments, a slit is defined along a wall defining the slot,the slit sized and configured to receive a saw blade therein forperforming a chamfer cut of a bone.

In some embodiments, a second cutting guide has a body defining a slothaving a width that is smaller than a width of the slot defined by thecutting base. The second cutting guide includes a set of pegs thatextend inferiorly from the second cutting guide and are sized andconfigured to be received with the first set of holes or the second setof holes to secure the second cutting guide to the cutting base.

A method includes coupling a cutting base to a resected surface of afirst bone. The cutting base includes a body defining a slot, a slitwithin the slot, a first set of holes, and a second set of holes. Thefirst set of holes being positioned along a first flange extending awayfrom the slot in a first direction, and the second set of holes beingpositioned along a second flange extending from the slot in a seconddirection that is opposite the first direction. A chamfer cut of thefirst bone is made by inserting a saw into the slit. A first cuttingguide is coupled to the cutting guide base by inserting inferiorlyextending pegs into the first set of holes. The first cutting guide hasa body defining a plurality of holes that overlap one another to form aslot having a width that is smaller than a width of the slot defined bythe cutting base. A reamer is plunged into each of the plurality ofholes defined by the first cutting guide to form a first flat. The firstcutting guide is rotated relative to the cutting guide base and iscoupled to the cutting guide base by inserting the inferiorly extendingpegs into the second set of holes. A reamer is plunged into each of theplurality of holes defined by the first cutting guide to form a secondflat.

In some embodiments, a method includes coupling a second cutting guideto the cutting guide base by inserting inferiorly extending pegs intothe first set of holes. The second cutting guide defines a slot having awidth that is narrower than a width of the slot defined cutting base. Areamer is moved along the slot defined by the second cutting guide toform a first final flat.

In some embodiments, a method includes rotating the second cutting guiderelative to the cutting guide base, coupling the second cutting guide tothe cutting guide base by inserting the inferiorly extending pegs intothe second set of holes, and moving a reamer along the slot defined bythe second cutting guide to form a second final flat.

In some embodiments, a surgical device includes a body including ahandle disposed at a first end and a locking protrusion extending adirection away from a longitudinal direction of the body. The lockingprotrusion defines an opening that is sized and configured to receive alocking tab therein and defining a hole that extends parallel to thelongitudinal direction of the body. The locking tab defines an aperturehaving first and second portions in which the first portion is narrowerthan the second portion. A pair of spaced apart rails are configured tobe disposed along a length of the body. A plunger rod is sized andconfigured to be received slidably within a threaded hole defined by thehandle, the aperture defined by the locking tab, and the hole defined bythe locking protrusion. The surgical device is configured to be coupledreleasably to a first implant component and to guide a second implantcomponent into position with respect to the first implant component.

In some embodiments, the plunger rod includes a handle at a proximal endand a shoulder having an enlarged diameter along a length of the plungerrod.

In some embodiments, the plunger rod includes a threaded portionadjacent to the shoulder. The threaded portion is configured to engagethe threaded hold defined by the handle.

In some embodiments, the plunger rod includes a reduced diameter regionadjacent to a distal end of the plunger rod. The reduced diameter regionhas a diameter that is sized and configured to be received within thefirst portion of the aperture defined by the locking tab for locking theplunger rod in a retracted position.

In some embodiments, a push bar includes an elongate body from which anextension protrudes. The extension is sized and configured to bereceived within a hole defined by the distal end of the plunger rod thatextends axially along the plunger rod.

In some embodiments, the extension defines a circumferential groove thatis sized and configured to receive a pin therein to cross-pin the pushbar to the distal end of the plunger rod such that the push bar is ableto rotate relative to the plunger rod.

In some embodiments, the body defines a channel along opposed lateralsides thereof each being sized and configured to receive an attachmentscrew for coupling the surgical device to the first implant component.

In some embodiments, a method includes coupling an insertion device to afirst implant component disposed within a joint, pushing a plunger rodof the insertion device axially to advance a second implant componentalong a body of the insertion device between a pair of spaced apartrails until a threaded portion of the plunger rod contacts a threadedhole defined by a handle of the insertion device, and rotating a handleof the plunger rod relative to the body of the insertion device suchthat the threads of the threaded portion of the plunger rod engagethreads of the threaded hole to advance the second implant componentinto engagement with the first implant component.

In some embodiments, coupling the insertion device to the first implantincludes coupling first and second attachment screws to the firstimplant component, inserting the body of the insertion device into aspace between the first and second attachment screws such that a freeend of each of the first and second attachment screw is received withina respective hole defined by the handle of the insertion device, andattaching a nut to each of the respective free ends of the first andsecond attachment screws.

In some embodiments, a method includes pulling the plunger rodproximally with respect to the body of the insertion device and lockingthe plunger rod relative to the body of the insertion device byadvancing a locking button relative to a locking protrusion of the bodyof the insertion device such that a reduced diameter portion of theplunger rod is received within a first portion of an aperture that has anarrower opening than a second portion of the aperture.

A method includes placing a guide having a patient-specific surface on afirst bone. The guide includes a pin holder that engages a pin thatextends in a direction that is parallel to an axis of the first bone. Aplurality of pins are inserted into the guide. The guide is slid alongthe plurality of pins to remove the guide from contacting the firstbone. A conversion instrument is slid over a first subset of theplurality of pins, and a sizing and drill guide is slid over a secondsubset of the plurality of pins. The conversion instrument is coupled tothe sizing and drill guide by inserting a dovetail extension of thesizing and drill guide into a cavity of a dovetail joint of theconversion instrument.

In some embodiments, a method includes using fluoroscopy to check a sizeof a radiopaque element of the sizing and drill guide relative to thefirst bone. The radiopaque element has a size and shape that correspondsto a profile of a prosthesis component of a first type having a firstsize when viewed in the anterior-posterior direction.

In some embodiments, the sizing and drill guide is a first sizing anddrill guide. A method includes uncoupling the first sizing and drillguide from the conversion instrument and the second subset of theplurality of pins, sliding a second sizing and drill guide over thesecond subset of the plurality of pins, and coupling the conversioninstrument to the second sizing and drill guide by inserting a dovetailextension of the second sizing and drill guide into the cavity of thedovetail joint of the conversion instrument.

In some embodiments, a surgical system includes a trial and a spacer.The trial is configured to be received within a resected first bone. Thetrial includes a plate having a bottom surface defining a channel. Thespacer has an elongate body and an extension disposed at one endthereof. The elongate body is sized and configured to be received withinchannel defined by the trial. The extension defining at least first andsecond holes that are configured to receive first and second pinspositioned within a second bone.

In some embodiments, a surgical system includes a cutting guide having afront face defining a plurality of holes and a slot. A first subset ofthe plurality of holes is configured to receive the first and secondpins such that cutting guide is positioned in a first position withrespect to the first bone. A second subset of the plurality of holes isconfigured to receive the first and second pins such that the cuttingguide is positioned in a second position with respect to the first bonethat is different from the first position.

In some embodiments, one of the plurality of holes is a hole that is atleast partially threaded for receiving a threaded rod to assist inremoving the spacer from the channel defined by the channel.

In some embodiments, the spacer is formed from a radiolucent material.

In some embodiments, the first bone is a tibia and the second bone is atalus.

In some embodiments, a method includes inserting an elongate body of aspacer into a channel defined by a trial positioned within a resectedfirst bone, inserting first and second pins through first and secondholes defined by an extension of the spacer that extends superiorly fromthe elongate body; and removing the spacer and the trial while leavingthe first and second pins positioned within the second bone. A cuttingguide is slid over the first and second pins.

In some embodiments, the first and second pins are received within afirst subset of a plurality of holes defined by the cutting guide or asecond subset of the plurality of pins defined by the cutting guide.

In some embodiments, the first subset of holes is positioned at a firstdistance from a slot defined by the cutting guide, and the second subsetof holes is positioned at a second distance from the slot that isdifferent from the first distance.

In some embodiments, a method includes resecting the second bone byinserting a cutting instrument in a slot defined by the cutting guide toresect the second bone.

In some embodiments, the first bone is a tibia and the second bone is atalus.

Although the subject matter has been described in terms of exemplaryembodiments, it is not limited thereto. Rather, the appended claimsshould be construed broadly, to include other variants and embodiments,which may be made by those skilled in the art.

What is claimed is:
 1. A system, comprising: a first surgical toolincluding a body having a first bone-contacting side and a second sidethat is disposed opposite the first bone-contacting side, the firstbone-contacting side including a patient-specific surface sized andconfigured to be coupled to a first bone of a patient, the second sideof the body including a pin holder extending from a superior portion ofthe second side in a direction away from the second side, the pin holderdefining a hole therethrough that defines an axis that is parallel to anaxis related to the first bone, the hole sized and configured to receivea pin therein, wherein the body defines a first set of holes that extendthrough an inferior portion of the body.
 2. The system of claim 1,wherein the first surgical tool includes a pin disposed within the hole,the pin formed from a radiopaque material.
 3. The system of claim 1,further comprising a second surgical tool defining a second set ofholes, wherein a position of the first set of holes defined by the firstsurgical tool correspond to a position of the second set of holesdefined by the second surgical tool.
 4. The system of claim 1, whereinthe bone comprises a tibia.
 5. The system of claim 4, wherein the axisis a longitudinal axis of the tibia.
 6. The system of claim 1, whereinthe axis is a mechanical axis.
 7. The system of claim 1, wherein thepatient-specific surface is configured to mate with a distal end of atibia.
 8. The system of claim 1, further comprising a second surgicaltool, wherein the first set of holes are positioned with respect to thebody of the first surgical tool such that they provide a guide fororienting a placement of the second surgical tool once the firstsurgical tool has been removed from an engagement with a first set ofpins received within the first set of holes.
 9. The system of claim 1,wherein the superior portion of the body defines a third set of holes.10. The system of claim 9, wherein the pin holder is located between atleast two of the third set of holes on the superior portion of the firstsurgical instrument.
 11. A method comprising: placing a guide having apatient-specific surface on a first bone, the guide including a pinholder that engages a pin that extends in a direction that is parallelto an axis related to the first bone, wherein the first bone is a tibia,and wherein the axis is at least one of a mechanical axis and ananatomical axis; and inserting a plurality of pins into a pair of spacedapart holes defined by the guide.
 12. The method of claim 11, furthercomprising: sliding the guide along the plurality of pins to remove theguide from contacting the first bone; and sliding a conversioninstrument over a first subset of the plurality of pins.